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Supplemental Table 1. A full list of the analyzed trials.
Autologous
Synthetic
Allogenic
(2.5x106 -1x108
cells)
Peptide
(10-5000
mcg)
DNA
(50-8000
mcg)
RNA
(200-640
mcg)
Virus
(1x103-1x1011
PFU)
Bacteria
(120-1650
mcg)
AntiIdiotypic
(3-2000
mcg)
Liposomal
(20-1000
mcg)
Lehner, 1990(2)
Osanto, 2000
(3)
Livingst
on, 1994
(4)
Conry,
2002 (5)
Weide, 2008
(6)
McAneny,
1996 (7)
Carr, 2003
(8)
Foon, 1997
(9)
Palmer, 2001
(10)
Veelken, 1997
(12)
Newton,
2001(13)
Cormier,
1997
(14)
Timmer
man,
2002
(15)
Weide, 2009
(16)
Conry, 1999
(17)
Guthmann,
2004 (18)
Foon, 1998
(19)
Ohyanagi,20
11 (20)
Small,
2000 (21)
Simons, 1997
(22)
Jaffee, 2001
(23)
Weber,
1999
(24)
Klencke,
2002
(25)
Marshall,
1999 (26)
Bertinetti,
2006 (27)
Smith, 2000
(28)
Panelli,
2000 (29)
Schreiber, 1999
(30)
Rousseau, 2003
(31)
Khleif,
1999
(32)
Pavlenko
, 2004
(33)
Sanda, 1999
(34)
Maciag,2009
(35)
Diaz, 2003
(36)
Geiger,
2001 (37)
Sobol, 1999
(38)
Dols, 2003 (39)
Van
Dreil,
1999
(40)
Triozzi,
2005
(41)
Eder, 2000
(42)
Maraveyas,
1999 (43)
Reinartz,
2004 (44)
Pecher,
2002 (45)
Jiang, 2000(46)
Marten,
2003(47)
Wang,
1999
(48)
Gribben,
2005
(49)
Von Mehren,
2000 (50)
Osorio, 2008
(51)
Zbar, 2005
(52)
Hernando, 2002
(53)
Kusumoto,
2001 (54)
Raez, 2004 (55)
Gilewski
, 2000
(56)
Wolchok
, 2007
(57)
Horig, 2000
(58)
Pfisterer,
2006 (59)
Chang,
2002 (60)
Dillman, 2004
(61)
Barrio,
2006(62)
PinillaIbarz,
2000
(63)
Cassaday
, 2007
(64)
Gomella,
2001 (65)
Quan, 1997
(66)
Kono,
2002 (67)
Moiseenko,
2004 (68)
Simons, 2006
(69)
Chapma
n, 2000
(70)
Weber,
2008
Mulvihill,
2001 (72)
Nicholson,
2004 (73)
Dentritic Cells
(1x105-1x109
cells)
Tumor
(2x105-3.7x108
cells)
Chakraborty,
1998 (1)
Mackensen,
2000 (11)
Supplemental Table 1. A full list of the analyzed trials.
(71)
Babatz, 2003
(74)
Butterfield,
2003(81)
O'Rourke, 2003
(88)
Tani, 2004(75)
Luiten, 2005
(82)
Moiseyenko,
2005 (89)
Avigan, 2007
(76)
Lewis,
2000
(77)
Yuan,
2009
(78)
Brill, 2007 (83)
Sabbatin
i, 2000
(84)
McNeel,
2009
(85)
Okaji,
2008(90)
Slingluff
, 2001
(91)
Low,
2009
(92)
Bedrosian, 2003
(95)
Spaner, 2005
(96)
Higano, 2008
(97)
Gohara,
2002
(98)
Brody,
2010
(99)
Reichardt, 2003
(102)
Biagi,
2005(103)
Urba,
2008(104)
Noguchi,
2003
(105)
Ginsberg
, 2010
(106)
Yamanaka,
2003 (108)
Dessureault,
2007 (109)
Buchner, 2010
(110)
Pullarkat
, 2003
(111)
Staff,
2010
(112)
Di Nicola,
2004(114)
Dillman,2007
(115)
Hirschowitz,
2011 (116)
Mitchell,
2004
(117)
Mincheff
, 2000
(118)
Caruso,2004(12
0)
Russell, 2007
(121)
Eaton, 2002
(122)
Disis,
2004
(123)
Tagawa,
2003
(124)
Nemunaitis,
2006* (128)
Ullenhag
, 2004
(129)
Hersey, 2004
(126)
Avigan, 2004
(131)
Maki,
2007(127)
Brill,
2009*(133)
Russell,
Tsuruma
, 2004
(134)
Gulley, 2002
(79)
Van der
Burg, 2002
(86)
Zajac, 2003
(93)
Rochlitz,
2003 (100)
Smith, 2005
(107)
Triozzi, 2005
(113)
Meyer, 2005
(119)
Laurie, 2006
(125)
Harrop, 2006
(130)
Kaufman,
2006 (135)
Sabbatini,
2006 (80)
Brett, 2002*
(87)
Chapman,
2004* (94)
Gilliam,
2004* (101)
Supplemental Table 1. A full list of the analyzed trials.
2008(132)
Yu, 2004(136)
Vonderheide,
2004 (140)
Liau, 2005
(144)
Morse, 2005
(148)
Linette, 2005
(152)
Caruso,2005(15
6)
Morse,
2005(160)
Yamanaka,
2005 (164)
Burgdorf, 2006
(168)
Lesimple, 2006
(172)
Thomas,
2006(176)
Smith,
2010(137)
Davis,
2004
(138)
Arlen, 2007
(139)
Eton, 2010
(141)
Noguchi,
2004
(142)
Kaufman,
2007 (143)
Olivares,
2011(145)
Yamamo
to, 2005
(146)
Gulley, 2008
(147)
Abel-Wahab,
1997(149)
Watersto
n, 2005
(150)
Lubaroff,
2009 (151)
Wittig,
2001(153)
Yamamo
to, 2005
(154)
Adamina,
2009 (155)
Meijer, 2002
(157)
Hueman,
2005
(158)
Hawkins,
2009 (159)
Mahvi, 2002
(161)
Kruit,
2005
(162)
Dangoor,
2010 (163)
Soiffer, 2003
(165)
Seledtso
v, 2006
(166)
Kimball,
2010 (167)
Salgia, 2003
(169)
Palefsky,
2006
(170)
Pantuck,
2004 (171)
Nemunaitis,
2004 (173)
Kitano,
2006
(174)
Marshall,
2005 (175)
Nemunaitis,
2006 (177)
Bernhar
dt, 2006
(178)
Galanis, 2010
(179)
Mavroud
is, 2006
Supplemental Table 1. A full list of the analyzed trials.
Kuwabara,
2007(180)
Morse, 2007
(183)
(181)
Morita,
2006
(184)
Dohnal, 2007
(185)
DiPaola,
2006
(186)
Kavanagh,
2007 (187)
Bins,
2007
(188)
Ovali, 2007
(189)
Von Euw, 2008
(191)
Sabbatin
i, 2007
(190)
Meyer,
2007
(192)
Butterfield,
2008 (193)
Kenter,
2008
(194)
Santin, 2008
(195)
Chianese
, 2008
(196)
Sampson, 2009
(197)
Tsuruma
, 2008
(198)
Van Driessche,
2009(199)
Trepiakas, 2010
(201)
Frank, 2010
Perales,
2008
(200)
Holmes,
2008
(202)
Rezvani,
2008
(204)
Safdar, 2006*
(182)
Supplemental Table 1. A full list of the analyzed trials.
(203)
Okada, 2011
(205)
Slingluff
, 2008
(206)
Rosenblatt,
2011(207)
Diefenba
ch, 2008
(208)
Haining, 2005
(209)
Kono,
2009
(210)
Park, 2007
(211)
Speetjen
s, 2009
(212)
Ruttinger, 2007
(213)
Feyerabe
nd, 2009
(214)
Peethambaram,
2009(215)
Timmer
man,
2009
(216)
Motohashi,
2009 (217)
Kaumay
a, 2009
(218)
Um, 2010 (219)
Giannop
oulos,
2010
(220)
Perroud, 2011
(221)
Wieder
mann,
2010
(222)
Pandha, 2004
(223)
Kowalsk
i, 2010
(224)
Katano,
2005(225)
Perez,
2010
(226)
Supplemental Table 1. A full list of the analyzed trials.
Banchereau,
2005 (227)
Carmich
ael, 2010
(228)
Loveland, 2006
(229)
Speiser,
2010
(230)
Curti,
2007(231)
Baba,
2010
(232)
Prins, 2011
(233)
Weber,
2011
(234)
Karbach,
2011
(235)
Terasaki,
2011
(236)
Krug,
2011
(237)
Kakimi,
2011
(238)
Oka,
2004
(239)
Ramanat
han,
2005
(240)
Supplemental Table 1. A full list of the analyzed trials.
Ramos,
2006
(241)
Di
Pucchio,
2006
(242)
Bender,
2007
(243)
Odunis,
2007
(244)
Ribas,
2011
(245)
Moulton,
2002*
(246)
Krug,
2004*
(247)
Holmes,
2008*
(248)
Peoples,
2008*
(249)
*Phase 2 trials that used a dose escalation design and tested for immune response as a primary
endpoint.
Supplemental Table 1. A full list of the analyzed trials.
1.
Chakraborty NG, Sporn JR, Tortora AF, Kurtzman SH, Yamase H, Ergin MT, et al. Immunization
with a tumor-cell-lysate-loaded autologous-antigen-presenting-cell-based vaccine in melanoma. Cancer
immunology, immunotherapy : CII. 1998;47:58-64.
2.
Lehner B, Schlag P, Liebrich W, Schirrmacher V. Postoperative active specific immunization in
curatively resected colorectal cancer patients with a virus-modified autologous tumor cell vaccine.
Cancer immunology, immunotherapy : CII. 1990;32:173-8.
3.
Osanto S, Schiphorst PP, Weijl NI, Dijkstra N, Van Wees A, Brouwenstein N, et al. Vaccination of
melanoma patients with an allogeneic, genetically modified interleukin 2-producing melanoma cell line.
Human gene therapy. 2000;11:739-50.
4.
Livingston PO, Adluri S, Helling F, Yao TJ, Kensil CR, Newman MJ, et al. Phase 1 trial of
immunological adjuvant QS-21 with a GM2 ganglioside-keyhole limpet haemocyanin conjugate vaccine
in patients with malignant melanoma. Vaccine. 1994;12:1275-80.
5.
Conry RM, Curiel DT, Strong TV, Moore SE, Allen KO, Barlow DL, et al. Safety and
immunogenicity of a DNA vaccine encoding carcinoembryonic antigen and hepatitis B surface antigen in
colorectal carcinoma patients. Clinical cancer research : an official journal of the American Association
for Cancer Research. 2002;8:2782-7.
6.
Weide B, Carralot JP, Reese A, Scheel B, Eigentler TK, Hoerr I, et al. Results of the first phase I/II
clinical vaccination trial with direct injection of mRNA. J Immunother. 2008;31:180-8.
7.
McAneny D, Ryan CA, Beazley RM, Kaufman HL. Results of a phase I trial of a recombinant
vaccinia virus that expresses carcinoembryonic antigen in patients with advanced colorectal cancer.
Annals of surgical oncology. 1996;3:495-500.
8.
Carr A, Rodriguez E, Arango Mdel C, Camacho R, Osorio M, Gabri M, et al. Immunotherapy of
advanced breast cancer with a heterophilic ganglioside (NeuGcGM3) cancer vaccine. Journal of clinical
oncology : official journal of the American Society of Clinical Oncology. 2003;21:1015-21.
9.
Foon KA, John WJ, Chakraborty M, Sherratt A, Garrison J, Flett M, et al. Clinical and immune
responses in advanced colorectal cancer patients treated with anti-idiotype monoclonal antibody
vaccine that mimics the carcinoembryonic antigen. Clinical cancer research : an official journal of the
American Association for Cancer Research. 1997;3:1267-76.
10.
Palmer M, Parker J, Modi S, Butts C, Smylie M, Meikle A, et al. Phase I study of the BLP25 (MUC1
peptide) liposomal vaccine for active specific immunotherapy in stage IIIB/IV non-small-cell lung cancer.
Clin Lung Cancer. 2001;3:49-57; discussion 8.
11.
Mackensen A, Herbst B, Chen JL, Kohler G, Noppen C, Herr W, et al. Phase I study in melanoma
patients of a vaccine with peptide-pulsed dendritic cells generated in vitro from CD34(+) hematopoietic
progenitor cells. International journal of cancer Journal international du cancer. 2000;86:385-92.
12.
Veelken H, Mackensen A, Lahn M, Kohler G, Becker D, Franke B, et al. A phase-I clinical study of
autologous tumor cells plus interleukin-2-gene-transfected allogeneic fibroblasts as a vaccine in patients
with cancer. International journal of cancer Journal international du cancer. 1997;70:269-77.
13.
Newton DA, Acierno PM, Metts MC, Baron PL, Brescia FJ, Gattoni-Celli S. Semiallogeneic cancer
vaccines formulated with granulocyte-macrophage colony-stimulating factor for patients with
metastatic gastrointestinal adenocarcinomas: a pilot phase I study. J Immunother. 2001;24:19-26.
14.
Cormier JN, Salgaller ML, Prevette T, Barracchini KC, Rivoltini L, Restifo NP, et al. Enhancement
of cellular immunity in melanoma patients immunized with a peptide from MART-1/Melan A. The cancer
journal from Scientific American. 1997;3:37-44.
Supplemental Table 1. A full list of the analyzed trials.
15.
Timmerman JM, Singh G, Hermanson G, Hobart P, Czerwinski DK, Taidi B, et al. Immunogenicity
of a plasmid DNA vaccine encoding chimeric idiotype in patients with B-cell lymphoma. Cancer research.
2002;62:5845-52.
16.
Weide B, Pascolo S, Scheel B, Derhovanessian E, Pflugfelder A, Eigentler TK, et al. Direct injection
of protamine-protected mRNA: results of a phase 1/2 vaccination trial in metastatic melanoma patients.
J Immunother. 2009;32:498-507.
17.
Conry RM, Khazaeli MB, Saleh MN, Allen KO, Barlow DL, Moore SE, et al. Phase I trial of a
recombinant vaccinia virus encoding carcinoembryonic antigen in metastatic adenocarcinoma:
comparison of intradermal versus subcutaneous administration. Clinical cancer research : an official
journal of the American Association for Cancer Research. 1999;5:2330-7.
18.
Guthmann MD, Bitton RJ, Carnero AJ, Gabri MR, Cinat G, Koliren L, et al. Active specific
immunotherapy of melanoma with a GM3 ganglioside-based vaccine: a report on safety and
immunogenicity. J Immunother. 2004;27:442-51.
19.
Foon KA, Sen G, Hutchins L, Kashala OL, Baral R, Banerjee M, et al. Antibody responses in
melanoma patients immunized with an anti-idiotype antibody mimicking disialoganglioside GD2. Clinical
cancer research : an official journal of the American Association for Cancer Research. 1998;4:1117-24.
20.
Ohyanagi F, Horai T, Sekine I, Yamamoto N, Nakagawa K, Nishio M, et al. Safety of BLP25
liposome vaccine (L-BLP25) in Japanese patients with unresectable stage III NSCLC after primary
chemoradiotherapy: preliminary results from a Phase I/II study. Japanese journal of clinical oncology.
2011;41:718-22.
21.
Small EJ, Fratesi P, Reese DM, Strang G, Laus R, Peshwa MV, et al. Immunotherapy of hormonerefractory prostate cancer with antigen-loaded dendritic cells. Journal of clinical oncology : official
journal of the American Society of Clinical Oncology. 2000;18:3894-903.
22.
Simons JW, Jaffee EM, Weber CE, Levitsky HI, Nelson WG, Carducci MA, et al. Bioactivity of
autologous irradiated renal cell carcinoma vaccines generated by ex vivo granulocyte-macrophage
colony-stimulating factor gene transfer. Cancer research. 1997;57:1537-46.
23.
Jaffee EM, Hruban RH, Biedrzycki B, Laheru D, Schepers K, Sauter PR, et al. Novel allogeneic
granulocyte-macrophage colony-stimulating factor-secreting tumor vaccine for pancreatic cancer: a
phase I trial of safety and immune activation. Journal of clinical oncology : official journal of the
American Society of Clinical Oncology. 2001;19:145-56.
24.
Weber JS, Hua FL, Spears L, Marty V, Kuniyoshi C, Celis E. A phase I trial of an HLA-A1 restricted
MAGE-3 epitope peptide with incomplete Freund's adjuvant in patients with resected high-risk
melanoma. J Immunother. 1999;22:431-40.
25.
Klencke B, Matijevic M, Urban RG, Lathey JL, Hedley ML, Berry M, et al. Encapsulated plasmid
DNA treatment for human papillomavirus 16-associated anal dysplasia: a Phase I study of ZYC101.
Clinical cancer research : an official journal of the American Association for Cancer Research.
2002;8:1028-37.
26.
Marshall JL, Hawkins MJ, Tsang KY, Richmond E, Pedicano JE, Zhu MZ, et al. Phase I study in
cancer patients of a replication-defective avipox recombinant vaccine that expresses human
carcinoembryonic antigen. Journal of clinical oncology : official journal of the American Society of
Clinical Oncology. 1999;17:332-7.
27.
Bertinetti C, Zirlik K, Heining-Mikesch K, Ihorst G, Dierbach H, Waller CF, et al. Phase I trial of a
novel intradermal idiotype vaccine in patients with advanced B-cell lymphoma: specific immune
responses despite profound immunosuppression. Cancer research. 2006;66:4496-502.
Supplemental Table 1. A full list of the analyzed trials.
28.
Smith AM, Justin T, Michaeli D, Watson SA. Phase I/II study of G17-DT, an anti-gastrin
immunogen, in advanced colorectal cancer. Clinical cancer research : an official journal of the American
Association for Cancer Research. 2000;6:4719-24.
29.
Panelli MC, Wunderlich J, Jeffries J, Wang E, Mixon A, Rosenberg SA, et al. Phase 1 study in
patients with metastatic melanoma of immunization with dendritic cells presenting epitopes derived
from the melanoma-associated antigens MART-1 and gp100. J Immunother. 2000;23:487-98.
30.
Schreiber S, Kampgen E, Wagner E, Pirkhammer D, Trcka J, Korschan H, et al. Immunotherapy of
metastatic malignant melanoma by a vaccine consisting of autologous interleukin 2-transfected cancer
cells: outcome of a phase I study. Human gene therapy. 1999;10:983-93.
31.
Rousseau RF, Haight AE, Hirschmann-Jax C, Yvon ES, Rill DR, Mei Z, et al. Local and systemic
effects of an allogeneic tumor cell vaccine combining transgenic human lymphotactin with interleukin-2
in patients with advanced or refractory neuroblastoma. Blood. 2003;101:1718-26.
32.
Khleif SN, Abrams SI, Hamilton JM, Bergmann-Leitner E, Chen A, Bastian A, et al. A phase I
vaccine trial with peptides reflecting ras oncogene mutations of solid tumors. J Immunother.
1999;22:155-65.
33.
Pavlenko M, Roos AK, Lundqvist A, Palmborg A, Miller AM, Ozenci V, et al. A phase I trial of DNA
vaccination with a plasmid expressing prostate-specific antigen in patients with hormone-refractory
prostate cancer. British journal of cancer. 2004;91:688-94.
34.
Sanda MG, Smith DC, Charles LG, Hwang C, Pienta KJ, Schlom J, et al. Recombinant vaccinia-PSA
(PROSTVAC) can induce a prostate-specific immune response in androgen-modulated human prostate
cancer. Urology. 1999;53:260-6.
35.
Maciag PC, Radulovic S, Rothman J. The first clinical use of a live-attenuated Listeria
monocytogenes vaccine: a Phase I safety study of Lm-LLO-E7 in patients with advanced carcinoma of the
cervix. Vaccine. 2009;27:3975-83.
36.
Diaz A, Alfonso M, Alonso R, Saurez G, Troche M, Catala M, et al. Immune responses in breast
cancer patients immunized with an anti-idiotype antibody mimicking NeuGc-containing gangliosides.
Clinical immunology. 2003;107:80-9.
37.
Geiger JD, Hutchinson RJ, Hohenkirk LF, McKenna EA, Yanik GA, Levine JE, et al. Vaccination of
pediatric solid tumor patients with tumor lysate-pulsed dendritic cells can expand specific T cells and
mediate tumor regression. Cancer research. 2001;61:8513-9.
38.
Sobol RE, Shawler DL, Carson C, Van Beveren C, Mercola D, Fakhrai H, et al. Interleukin 2 gene
therapy of colorectal carcinoma with autologous irradiated tumor cells and genetically engineered
fibroblasts: a Phase I study. Clinical cancer research : an official journal of the American Association for
Cancer Research. 1999;5:2359-65.
39.
Dols A, Smith JW, 2nd, Meijer SL, Fox BA, Hu HM, Walker E, et al. Vaccination of women with
metastatic breast cancer, using a costimulatory gene (CD80)-modified, HLA-A2-matched, allogeneic,
breast cancer cell line: clinical and immunological results. Human gene therapy. 2003;14:1117-23.
40.
van Driel WJ, Ressing ME, Kenter GG, Brandt RM, Krul EJ, van Rossum AB, et al. Vaccination with
HPV16 peptides of patients with advanced cervical carcinoma: clinical evaluation of a phase I-II trial. Eur
J Cancer. 1999;35:946-52.
41.
Triozzi PL, Aldrich W, Allen KO, Carlisle RR, LoBuglio AF, Conry RM. Phase I study of a plasmid
DNA vaccine encoding MART-1 in patients with resected melanoma at risk for relapse. J Immunother.
2005;28:382-8.
42.
Eder JP, Kantoff PW, Roper K, Xu GX, Bubley GJ, Boyden J, et al. A phase I trial of a recombinant
vaccinia virus expressing prostate-specific antigen in advanced prostate cancer. Clinical cancer research :
an official journal of the American Association for Cancer Research. 2000;6:1632-8.
Supplemental Table 1. A full list of the analyzed trials.
43.
Maraveyas A, Baban B, Kennard D, Rook GA, Westby M, Grange JM, et al. Possible improved
survival of patients with stage IV AJCC melanoma receiving SRL 172 immunotherapy: correlation with
induction of increased levels of intracellular interleukin-2 in peripheral blood lymphocytes. Annals of
oncology : official journal of the European Society for Medical Oncology / ESMO. 1999;10:817-24.
44.
Reinartz S, Kohler S, Schlebusch H, Krista K, Giffels P, Renke K, et al. Vaccination of patients with
advanced ovarian carcinoma with the anti-idiotype ACA125: immunological response and survival
(phase Ib/II). Clinical cancer research : an official journal of the American Association for Cancer
Research. 2004;10:1580-7.
45.
Pecher G, Haring A, Kaiser L, Thiel E. Mucin gene (MUC1) transfected dendritic cells as vaccine:
results of a phase I/II clinical trial. Cancer immunology, immunotherapy : CII. 2002;51:669-73.
46.
Jiang XP, Yang DC, Elliott RL, Head JF. Vaccination with a mixed vaccine of autogenous and
allogeneic breast cancer cells and tumor associated antigens CA15-3, CEA and CA125--results in immune
and clinical responses in breast cancer patients. Cancer biotherapy & radiopharmaceuticals.
2000;15:495-505.
47.
Marten A, Renoth S, Heinicke T, Albers P, Pauli A, Mey U, et al. Allogeneic dendritic cells fused
with tumor cells: preclinical results and outcome of a clinical phase I/II trial in patients with metastatic
renal cell carcinoma. Human gene therapy. 2003;14:483-94.
48.
Wang F, Bade E, Kuniyoshi C, Spears L, Jeffery G, Marty V, et al. Phase I trial of a MART-1 peptide
vaccine with incomplete Freund's adjuvant for resected high-risk melanoma. Clinical cancer research : an
official journal of the American Association for Cancer Research. 1999;5:2756-65.
49.
Gribben JG, Ryan DP, Boyajian R, Urban RG, Hedley ML, Beach K, et al. Unexpected association
between induction of immunity to the universal tumor antigen CYP1B1 and response to next therapy.
Clinical cancer research : an official journal of the American Association for Cancer Research.
2005;11:4430-6.
50.
von Mehren M, Arlen P, Tsang KY, Rogatko A, Meropol N, Cooper HS, et al. Pilot study of a dual
gene recombinant avipox vaccine containing both carcinoembryonic antigen (CEA) and B7.1 transgenes
in patients with recurrent CEA-expressing adenocarcinomas. Clinical cancer research : an official journal
of the American Association for Cancer Research. 2000;6:2219-28.
51.
Osorio M, Gracia E, Rodriguez E, Saurez G, Arango Mdel C, Noris E, et al. Heterophilic
NeuGcGM3 ganglioside cancer vaccine in advanced melanoma patients: results of a Phase Ib/IIa study.
Cancer biology & therapy. 2008;7:488-95.
52.
Zbar AP, Thomas H, Wilkinson RW, Wadhwa M, Syrigos KN, Ross EL, et al. Immune responses in
advanced colorectal cancer following repeated intradermal vaccination with the anti-CEA murine
monoclonal antibody, PR1A3: results of a phase I study. International journal of colorectal disease.
2005;20:403-14.
53.
Hernando JJ, Park TW, Kubler K, Offergeld R, Schlebusch H, Bauknecht T. Vaccination with
autologous tumour antigen-pulsed dendritic cells in advanced gynaecological malignancies: clinical and
immunological evaluation of a phase I trial. Cancer immunology, immunotherapy : CII. 2002;51:45-52.
54.
Kusumoto M, Umeda S, Ikubo A, Aoki Y, Tawfik O, Oben R, et al. Phase 1 clinical trial of
irradiated autologous melanoma cells adenovirally transduced with human GM-CSF gene. Cancer
immunology, immunotherapy : CII. 2001;50:373-81.
55.
Raez LE, Cassileth PA, Schlesselman JJ, Sridhar K, Padmanabhan S, Fisher EZ, et al. Allogeneic
vaccination with a B7.1 HLA-A gene-modified adenocarcinoma cell line in patients with advanced nonsmall-cell lung cancer. Journal of clinical oncology : official journal of the American Society of Clinical
Oncology. 2004;22:2800-7.
Supplemental Table 1. A full list of the analyzed trials.
56.
Gilewski T, Adluri S, Ragupathi G, Zhang S, Yao TJ, Panageas K, et al. Vaccination of high-risk
breast cancer patients with mucin-1 (MUC1) keyhole limpet hemocyanin conjugate plus QS-21. Clinical
cancer research : an official journal of the American Association for Cancer Research. 2000;6:1693-701.
57.
Wolchok JD, Yuan J, Houghton AN, Gallardo HF, Rasalan TS, Wang J, et al. Safety and
immunogenicity of tyrosinase DNA vaccines in patients with melanoma. Molecular therapy : the journal
of the American Society of Gene Therapy. 2007;15:2044-50.
58.
Horig H, Lee DS, Conkright W, Divito J, Hasson H, LaMare M, et al. Phase I clinical trial of a
recombinant canarypoxvirus (ALVAC) vaccine expressing human carcinoembryonic antigen and the B7.1
co-stimulatory molecule. Cancer immunology, immunotherapy : CII. 2000;49:504-14.
59.
Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, et al. The anti-idiotypic antibody
abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Annals of
oncology : official journal of the European Society for Medical Oncology / ESMO. 2006;17:1568-77.
60.
Chang AE, Redman BG, Whitfield JR, Nickoloff BJ, Braun TM, Lee PP, et al. A phase I trial of
tumor lysate-pulsed dendritic cells in the treatment of advanced cancer. Clinical cancer research : an
official journal of the American Association for Cancer Research. 2002;8:1021-32.
61.
Dillman R, Barth N, Selvan S, Beutel L, de Leon C, DePriest C, et al. Phase I/II trial of autologous
tumor cell line-derived vaccines for recurrent or metastatic sarcomas. Cancer biotherapy &
radiopharmaceuticals. 2004;19:581-8.
62.
Barrio MM, de Motta PT, Kaplan J, von Euw EM, Bravo AI, Chacon RD, et al. A phase I study of an
allogeneic cell vaccine (VACCIMEL) with GM-CSF in melanoma patients. J Immunother. 2006;29:444-54.
63.
Pinilla-Ibarz J, Cathcart K, Korontsvit T, Soignet S, Bocchia M, Caggiano J, et al. Vaccination of
patients with chronic myelogenous leukemia with bcr-abl oncogene breakpoint fusion peptides
generates specific immune responses. Blood. 2000;95:1781-7.
64.
Cassaday RD, Sondel PM, King DM, Macklin MD, Gan J, Warner TF, et al. A phase I study of
immunization using particle-mediated epidermal delivery of genes for gp100 and GM-CSF into
uninvolved skin of melanoma patients. Clinical cancer research : an official journal of the American
Association for Cancer Research. 2007;13:540-9.
65.
Gomella LG, Mastrangelo MJ, McCue PA, Maguire HJ, Mulholland SG, Lattime EC. Phase i study
of intravesical vaccinia virus as a vector for gene therapy of bladder cancer. The Journal of urology.
2001;166:1291-5.
66.
Quan WD, Jr., Dean GE, Spears L, Spears CP, Groshen S, Merritt JA, et al. Active specific
immunotherapy of metastatic melanoma with an antiidiotype vaccine: a phase I/II trial of I-Mel-2 plus
SAF-m. Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
1997;15:2103-10.
67.
Kono K, Takahashi A, Sugai H, Fujii H, Choudhury AR, Kiessling R, et al. Dendritic cells pulsed with
HER-2/neu-derived peptides can induce specific T-cell responses in patients with gastric cancer. Clinical
cancer research : an official journal of the American Association for Cancer Research. 2002;8:3394-400.
68.
Moiseenko VM, Danilov AO, Baldueva IA, Danilova AB, Tiukavina NV, Larin SS, et al. [Phase I-II
trial of gene therapy with tag-7 modified autologous tumor cells in patients with metastatic solid
tumors]. Voprosy onkologii. 2004;50:293-303.
69.
Simons JW, Sacks N. Granulocyte-macrophage colony-stimulating factor-transduced allogeneic
cancer cellular immunotherapy: the GVAX vaccine for prostate cancer. Urologic oncology. 2006;24:41924.
70.
Chapman PB, Morrisey D, Panageas KS, Williams L, Lewis JJ, Israel RJ, et al. Vaccination with a
bivalent G(M2) and G(D2) ganglioside conjugate vaccine: a trial comparing doses of G(D2)-keyhole
Supplemental Table 1. A full list of the analyzed trials.
limpet hemocyanin. Clinical cancer research : an official journal of the American Association for Cancer
Research. 2000;6:4658-62.
71.
Weber J, Boswell W, Smith J, Hersh E, Snively J, Diaz M, et al. Phase 1 trial of intranodal injection
of a Melan-A/MART-1 DNA plasmid vaccine in patients with stage IV melanoma. J Immunother.
2008;31:215-23.
72.
Mulvihill S, Warren R, Venook A, Adler A, Randlev B, Heise C, et al. Safety and feasibility of
injection with an E1B-55 kDa gene-deleted, replication-selective adenovirus (ONYX-015) into primary
carcinomas of the pancreas: a phase I trial. Gene therapy. 2001;8:308-15.
73.
Nicholson S, Bomphray CC, Thomas H, McIndoe A, Barton D, Gore M, et al. A phase I trial of
idiotypic vaccination with HMFG1 in ovarian cancer. Cancer immunology, immunotherapy : CII.
2004;53:809-16.
74.
Babatz J, Rollig C, Oelschlagel U, Zhao S, Ehninger G, Schmitz M, et al. Large-scale
immunomagnetic selection of CD14+ monocytes to generate dendritic cells for cancer immunotherapy:
a phase I study. Journal of hematotherapy & stem cell research. 2003;12:515-23.
75.
Tani K, Azuma M, Nakazaki Y, Oyaizu N, Hase H, Ohata J, et al. Phase I study of autologous tumor
vaccines transduced with the GM-CSF gene in four patients with stage IV renal cell cancer in Japan:
clinical and immunological findings. Molecular therapy : the journal of the American Society of Gene
Therapy. 2004;10:799-816.
76.
Avigan DE, Vasir B, George DJ, Oh WK, Atkins MB, McDermott DF, et al. Phase I/II study of
vaccination with electrofused allogeneic dendritic cells/autologous tumor-derived cells in patients with
stage IV renal cell carcinoma. J Immunother. 2007;30:749-61.
77.
Lewis JJ, Janetzki S, Schaed S, Panageas KS, Wang S, Williams L, et al. Evaluation of CD8(+) T-cell
frequencies by the Elispot assay in healthy individuals and in patients with metastatic melanoma
immunized with tyrosinase peptide. International journal of cancer Journal international du cancer.
2000;87:391-8.
78.
Yang X, Yuan X, Cai D, Wang S, Zong L. Low molecular weight chitosan in DNA vaccine delivery
via mucosa. International journal of pharmaceutics. 2009;375:123-32.
79.
Gulley J, Chen AP, Dahut W, Arlen PM, Bastian A, Steinberg SM, et al. Phase I study of a vaccine
using recombinant vaccinia virus expressing PSA (rV-PSA) in patients with metastatic androgenindependent prostate cancer. The Prostate. 2002;53:109-17.
80.
Sabbatini P, Dupont J, Aghajanian C, Derosa F, Poynor E, Anderson S, et al. Phase I study of
abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clinical
cancer research : an official journal of the American Association for Cancer Research. 2006;12:5503-10.
81.
Butterfield LH, Ribas A, Dissette VB, Amarnani SN, Vu HT, Oseguera D, et al. Determinant
spreading associated with clinical response in dendritic cell-based immunotherapy for malignant
melanoma. Clinical cancer research : an official journal of the American Association for Cancer Research.
2003;9:998-1008.
82.
Luiten RM, Kueter EW, Mooi W, Gallee MP, Rankin EM, Gerritsen WR, et al. Immunogenicity,
including vitiligo, and feasibility of vaccination with autologous GM-CSF-transduced tumor cells in
metastatic melanoma patients. Journal of clinical oncology : official journal of the American Society of
Clinical Oncology. 2005;23:8978-91.
83.
Brill TH, Kubler HR, von Randenborgh H, Fend F, Pohla H, Breul J, et al. Allogeneic retrovirally
transduced, IL-2- and IFN-gamma-secreting cancer cell vaccine in patients with hormone refractory
prostate cancer--a phase I clinical trial. The journal of gene medicine. 2007;9:547-60.
Supplemental Table 1. A full list of the analyzed trials.
84.
Sabbatini PJ, Kudryashov V, Ragupathi G, Danishefsky SJ, Livingston PO, Bornmann W, et al.
Immunization of ovarian cancer patients with a synthetic Lewis(y)-protein conjugate vaccine: a phase 1
trial. International journal of cancer Journal international du cancer. 2000;87:79-85.
85.
McNeel DG, Dunphy EJ, Davies JG, Frye TP, Johnson LE, Staab MJ, et al. Safety and
immunological efficacy of a DNA vaccine encoding prostatic acid phosphatase in patients with stage D0
prostate cancer. Journal of clinical oncology : official journal of the American Society of Clinical
Oncology. 2009;27:4047-54.
86.
van der Burg SH, Menon AG, Redeker A, Bonnet MC, Drijfhout JW, Tollenaar RA, et al. Induction
of p53-specific immune responses in colorectal cancer patients receiving a recombinant ALVAC-p53
candidate vaccine. Clinical cancer research : an official journal of the American Association for Cancer
Research. 2002;8:1019-27.
87.
Brett BT, Smith SC, Bouvier CV, Michaeli D, Hochhauser D, Davidson BR, et al. Phase II study of
anti-gastrin-17 antibodies, raised to G17DT, in advanced pancreatic cancer. Journal of clinical oncology :
official journal of the American Society of Clinical Oncology. 2002;20:4225-31.
88.
O'Rourke MG, Johnson M, Lanagan C, See J, Yang J, Bell JR, et al. Durable complete clinical
responses in a phase I/II trial using an autologous melanoma cell/dendritic cell vaccine. Cancer
immunology, immunotherapy : CII. 2003;52:387-95.
89.
Moiseyenko VM, Danilov AO, Baldueva IA, Danilova AB, Tyukavina NV, Larin SS, et al. Phase I/II
trial of gene therapy with autologous tumor cells modified with tag7/PGRP-S gene in patients with
disseminated solid tumors: miscellaneous tumors. Annals of oncology : official journal of the European
Society for Medical Oncology / ESMO. 2005;16:162-8.
90.
Okaji Y, Tsuno NH, Tanaka M, Yoneyama S, Matsuhashi M, Kitayama J, et al. Pilot study of antiangiogenic vaccine using fixed whole endothelium in patients with progressive malignancy after failure
of conventional therapy. Eur J Cancer. 2008;44:383-90.
91.
Slingluff CL, Jr., Yamshchikov G, Neese P, Galavotti H, Eastham S, Engelhard VH, et al. Phase I
trial of a melanoma vaccine with gp100(280-288) peptide and tetanus helper peptide in adjuvant:
immunologic and clinical outcomes. Clinical cancer research : an official journal of the American
Association for Cancer Research. 2001;7:3012-24.
92.
Low L, Mander A, McCann K, Dearnaley D, Tjelle T, Mathiesen I, et al. DNA vaccination with
electroporation induces increased antibody responses in patients with prostate cancer. Human gene
therapy. 2009;20:1269-78.
93.
Zajac P, Oertli D, Marti W, Adamina M, Bolli M, Guller U, et al. Phase I/II clinical trial of a
nonreplicative vaccinia virus expressing multiple HLA-A0201-restricted tumor-associated epitopes and
costimulatory molecules in metastatic melanoma patients. Human gene therapy. 2003;14:1497-510.
94.
Chapman PB, Williams L, Salibi N, Hwu WJ, Krown SE, Livingston PO. A phase II trial comparing
five dose levels of BEC2 anti-idiotypic monoclonal antibody vaccine that mimics GD3 ganglioside.
Vaccine. 2004;22:2904-9.
95.
Bedrosian I, Mick R, Xu S, Nisenbaum H, Faries M, Zhang P, et al. Intranodal administration of
peptide-pulsed mature dendritic cell vaccines results in superior CD8+ T-cell function in melanoma
patients. Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
2003;21:3826-35.
96.
Spaner DE, Hammond C, Mena J, Foden C, Deabreu A. A phase I/II trial of oxidized autologous
tumor vaccines during the "watch and wait" phase of chronic lymphocytic leukemia. Cancer
immunology, immunotherapy : CII. 2005;54:635-46.
Supplemental Table 1. A full list of the analyzed trials.
97.
Higano CS, Corman JM, Smith DC, Centeno AS, Steidle CP, Gittleman M, et al. Phase 1/2 doseescalation study of a GM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormonerefractory prostate cancer. Cancer. 2008;113:975-84.
98.
Gohara R, Imai N, Rikimaru T, Yamada A, Hida N, Ichiki M, et al. Phase 1 clinical study of
cyclophilin B peptide vaccine for patients with lung cancer. J Immunother. 2002;25:439-44.
99.
Brody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, et al. In situ vaccination with a
TLR9 agonist induces systemic lymphoma regression: a phase I/II study. Journal of clinical oncology :
official journal of the American Society of Clinical Oncology. 2010;28:4324-32.
100. Rochlitz C, Figlin R, Squiban P, Salzberg M, Pless M, Herrmann R, et al. Phase I immunotherapy
with a modified vaccinia virus (MVA) expressing human MUC1 as antigen-specific immunotherapy in
patients with MUC1-positive advanced cancer. The journal of gene medicine. 2003;5:690-9.
101. Gilliam AD, Watson SA, Henwood M, McKenzie AJ, Humphreys JE, Elder J, et al. A phase II study
of G17DT in gastric carcinoma. Eur J Surg Oncol. 2004;30:536-43.
102. Reichardt VL, Milazzo C, Brugger W, Einsele H, Kanz L, Brossart P. Idiotype vaccination of
multiple myeloma patients using monocyte-derived dendritic cells. Haematologica. 2003;88:1139-49.
103. Biagi E, Rousseau R, Yvon E, Schwartz M, Dotti G, Foster A, et al. Responses to human CD40
ligand/human interleukin-2 autologous cell vaccine in patients with B-cell chronic lymphocytic leukemia.
Clinical cancer research : an official journal of the American Association for Cancer Research.
2005;11:6916-23.
104. Urba WJ, Nemunaitis J, Marshall F, Smith DC, Hege KM, Ma J, et al. Treatment of biochemical
recurrence of prostate cancer with granulocyte-macrophage colony-stimulating factor secreting,
allogeneic, cellular immunotherapy. The Journal of urology. 2008;180:2011-7; discussion 7-8.
105. Noguchi M, Kobayashi K, Suetsugu N, Tomiyasu K, Suekane S, Yamada A, et al. Induction of
cellular and humoral immune responses to tumor cells and peptides in HLA-A24 positive hormonerefractory prostate cancer patients by peptide vaccination. The Prostate. 2003;57:80-92.
106. Ginsberg BA, Gallardo HF, Rasalan TS, Adamow M, Mu Z, Tandon S, et al. Immunologic response
to xenogeneic gp100 DNA in melanoma patients: comparison of particle-mediated epidermal delivery
with intramuscular injection. Clinical cancer research : an official journal of the American Association for
Cancer Research. 2010;16:4057-65.
107. Smith CL, Mirza F, Pasquetto V, Tscharke DC, Palmowski MJ, Dunbar PR, et al.
Immunodominance of poxviral-specific CTL in a human trial of recombinant-modified vaccinia Ankara. J
Immunol. 2005;175:8431-7.
108. Yamanaka R, Abe T, Yajima N, Tsuchiya N, Homma J, Kobayashi T, et al. Vaccination of recurrent
glioma patients with tumour lysate-pulsed dendritic cells elicits immune responses: results of a clinical
phase I/II trial. British journal of cancer. 2003;89:1172-9.
109. Dessureault S, Noyes D, Lee D, Dunn M, Janssen W, Cantor A, et al. A phase-I trial using a
universal GM-CSF-producing and CD40L-expressing bystander cell line (GM.CD40L) in the formulation of
autologous tumor cell-based vaccines for cancer patients with stage IV disease. Annals of surgical
oncology. 2007;14:869-84.
110. Buchner A, Pohla H, Willimsky G, Frankenberger B, Frank R, Baur-Melnyk A, et al. Phase 1 trial of
allogeneic gene-modified tumor cell vaccine RCC-26/CD80/IL-2 in patients with metastatic renal cell
carcinoma. Human gene therapy. 2010;21:285-97.
111. Pullarkat V, Lee PP, Scotland R, Rubio V, Groshen S, Gee C, et al. A phase I trial of SD-9427
(progenipoietin) with a multipeptide vaccine for resected metastatic melanoma. Clinical cancer research
: an official journal of the American Association for Cancer Research. 2003;9:1301-12.
Supplemental Table 1. A full list of the analyzed trials.
112. Staff C, Mozaffari F, Haller BK, Wahren B, Liljefors M. A Phase I safety study of plasmid DNA
immunization targeting carcinoembryonic antigen in colorectal cancer patients. Vaccine. 2011;29:681722.
113. Triozzi PL, Allen KO, Carlisle RR, Craig M, LoBuglio AF, Conry RM. Phase I study of the
intratumoral administration of recombinant canarypox viruses expressing B7.1 and interleukin 12 in
patients with metastatic melanoma. Clinical cancer research : an official journal of the American
Association for Cancer Research. 2005;11:4168-75.
114. Di Nicola M, Carlo-Stella C, Mortarini R, Baldassari P, Guidetti A, Gallino GF, et al. Boosting T cellmediated immunity to tyrosinase by vaccinia virus-transduced, CD34(+)-derived dendritic cell
vaccination: a phase I trial in metastatic melanoma. Clinical cancer research : an official journal of the
American Association for Cancer Research. 2004;10:5381-90.
115. Dillman RO, DePriest C, DeLeon C, Barth NM, Schwartzberg LS, Beutel LD, et al. Patient-specific
vaccines derived from autologous tumor cell lines as active specific immunotherapy: results of
exploratory phase I/II trials in patients with metastatic melanoma. Cancer biotherapy &
radiopharmaceuticals. 2007;22:309-21.
116. Hirschowitz EA, Mullins A, Prajapati D, Baeker T, Kloecker G, Foody T, et al. Pilot study of 1650G: a simplified cellular vaccine for lung cancer. Journal of thoracic oncology : official publication of the
International Association for the Study of Lung Cancer. 2011;6:169-73.
117. Mitchell MS, Kan-Mitchell J, Morrow PR, Darrah D, Jones VE, Mescher MF. Phase I trial of large
multivalent immunogen derived from melanoma lysates in patients with disseminated melanoma.
Clinical cancer research : an official journal of the American Association for Cancer Research.
2004;10:76-83.
118. Mincheff M, Tchakarov S, Zoubak S, Loukinov D, Botev C, Altankova I, et al. Naked DNA and
adenoviral immunizations for immunotherapy of prostate cancer: a phase I/II clinical trial. European
urology. 2000;38:208-17.
119. Meyer RG, Britten CM, Siepmann U, Petzold B, Sagban TA, Lehr HA, et al. A phase I vaccination
study with tyrosinase in patients with stage II melanoma using recombinant modified vaccinia virus
Ankara (MVA-hTyr). Cancer immunology, immunotherapy : CII. 2005;54:453-67.
120. Caruso DA, Orme LM, Neale AM, Radcliff FJ, Amor GM, Maixner W, et al. Results of a phase 1
study utilizing monocyte-derived dendritic cells pulsed with tumor RNA in children and young adults
with brain cancer. Neuro-oncology. 2004;6:236-46.
121. Russell HV, Strother D, Mei Z, Rill D, Popek E, Biagi E, et al. Phase I trial of vaccination with
autologous neuroblastoma tumor cells genetically modified to secrete IL-2 and lymphotactin. J
Immunother. 2007;30:227-33.
122. Eaton JD, Perry MJ, Nicholson S, Guckian M, Russell N, Whelan M, et al. Allogeneic whole-cell
vaccine: a phase I/II study in men with hormone-refractory prostate cancer. BJU international.
2002;89:19-26.
123. Disis ML, Schiffman K, Guthrie K, Salazar LG, Knutson KL, Goodell V, et al. Effect of dose on
immune response in patients vaccinated with an her-2/neu intracellular domain protein--based vaccine.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2004;22:191625.
124. Tagawa ST, Lee P, Snively J, Boswell W, Ounpraseuth S, Lee S, et al. Phase I study of intranodal
delivery of a plasmid DNA vaccine for patients with Stage IV melanoma. Cancer. 2003;98:144-54.
125. Laurie SA, Bell JC, Atkins HL, Roach J, Bamat MK, O'Neil JD, et al. A phase 1 clinical study of
intravenous administration of PV701, an oncolytic virus, using two-step desensitization. Clinical cancer
research : an official journal of the American Association for Cancer Research. 2006;12:2555-62.
Supplemental Table 1. A full list of the analyzed trials.
126. Hersey P, Menzies SW, Halliday GM, Nguyen T, Farrelly ML, DeSilva C, et al. Phase I/II study of
treatment with dendritic cell vaccines in patients with disseminated melanoma. Cancer immunology,
immunotherapy : CII. 2004;53:125-34.
127. Maki RG, Livingston PO, Lewis JJ, Janetzki S, Klimstra D, Desantis D, et al. A phase I pilot study of
autologous heat shock protein vaccine HSPPC-96 in patients with resected pancreatic adenocarcinoma.
Digestive diseases and sciences. 2007;52:1964-72.
128. Nemunaitis J, Dillman RO, Schwarzenberger PO, Senzer N, Cunningham C, Cutler J, et al. Phase II
study of belagenpumatucel-L, a transforming growth factor beta-2 antisense gene-modified allogeneic
tumor cell vaccine in non-small-cell lung cancer. Journal of clinical oncology : official journal of the
American Society of Clinical Oncology. 2006;24:4721-30.
129. Ullenhag GJ, Frodin JE, Jeddi-Tehrani M, Strigard K, Eriksson E, Samanci A, et al. Durable
carcinoembryonic antigen (CEA)-specific humoral and cellular immune responses in colorectal
carcinoma patients vaccinated with recombinant CEA and granulocyte/macrophage colony-stimulating
factor. Clinical cancer research : an official journal of the American Association for Cancer Research.
2004;10:3273-81.
130. Harrop R, Connolly N, Redchenko I, Valle J, Saunders M, Ryan MG, et al. Vaccination of
colorectal cancer patients with modified vaccinia Ankara delivering the tumor antigen 5T4 (TroVax)
induces immune responses which correlate with disease control: a phase I/II trial. Clinical cancer
research : an official journal of the American Association for Cancer Research. 2006;12:3416-24.
131. Avigan D, Vasir B, Gong J, Borges V, Wu Z, Uhl L, et al. Fusion cell vaccination of patients with
metastatic breast and renal cancer induces immunological and clinical responses. Clinical cancer
research : an official journal of the American Association for Cancer Research. 2004;10:4699-708.
132. Russell HV, Strother D, Mei Z, Rill D, Popek E, Biagi E, et al. A phase 1/2 study of autologous
neuroblastoma tumor cells genetically modified to secrete IL-2 in patients with high-risk neuroblastoma.
J Immunother. 2008;31:812-9.
133. Brill TH, Kubler HR, Pohla H, Buchner A, Fend F, Schuster T, et al. Therapeutic vaccination with
an interleukin-2-interferon-gamma-secreting allogeneic tumor vaccine in patients with progressive
castration-resistant prostate cancer: a phase I/II trial. Human gene therapy. 2009;20:1641-51.
134. Tsuruma T, Hata F, Torigoe T, Furuhata T, Idenoue S, Kurotaki T, et al. Phase I clinical study of
anti-apoptosis protein, survivin-derived peptide vaccine therapy for patients with advanced or recurrent
colorectal cancer. Journal of translational medicine. 2004;2:19.
135. Kaufman HL, Cohen S, Cheung K, DeRaffele G, Mitcham J, Moroziewicz D, et al. Local delivery of
vaccinia virus expressing multiple costimulatory molecules for the treatment of established tumors.
Human gene therapy. 2006;17:239-44.
136. Yu JS, Liu G, Ying H, Yong WH, Black KL, Wheeler CJ. Vaccination with tumor lysate-pulsed
dendritic cells elicits antigen-specific, cytotoxic T-cells in patients with malignant glioma. Cancer
research. 2004;64:4973-9.
137. Smith BD, Kasamon YL, Kowalski J, Gocke C, Murphy K, Miller CB, et al. K562/GM-CSF
immunotherapy reduces tumor burden in chronic myeloid leukemia patients with residual disease on
imatinib mesylate. Clinical cancer research : an official journal of the American Association for Cancer
Research. 2010;16:338-47.
138. Davis ID, Chen W, Jackson H, Parente P, Shackleton M, Hopkins W, et al. Recombinant NY-ESO-1
protein with ISCOMATRIX adjuvant induces broad integrated antibody and CD4(+) and CD8(+) T cell
responses in humans. Proceedings of the National Academy of Sciences of the United States of America.
2004;101:10697-702.
Supplemental Table 1. A full list of the analyzed trials.
139. Arlen PM, Skarupa L, Pazdur M, Seetharam M, Tsang KY, Grosenbach DW, et al. Clinical safety of
a viral vector based prostate cancer vaccine strategy. The Journal of urology. 2007;178:1515-20.
140. Vonderheide RH, Domchek SM, Schultze JL, George DJ, Hoar KM, Chen DY, et al. Vaccination of
cancer patients against telomerase induces functional antitumor CD8+ T lymphocytes. Clinical cancer
research : an official journal of the American Association for Cancer Research. 2004;10:828-39.
141. Eton O, Ross MI, East MJ, Mansfield PF, Papadopoulos N, Ellerhorst JA, et al. Autologous tumorderived heat-shock protein peptide complex-96 (HSPPC-96) in patients with metastatic melanoma.
Journal of translational medicine. 2010;8:9.
142. Noguchi M, Itoh K, Suekane S, Morinaga A, Sukehiro A, Suetsugu N, et al. Immunological
monitoring during combination of patient-oriented peptide vaccination and estramustine phosphate in
patients with metastatic hormone refractory prostate cancer. The Prostate. 2004;60:32-45.
143. Kaufman HL, Kim-Schulze S, Manson K, DeRaffele G, Mitcham J, Seo KS, et al. Poxvirus-based
vaccine therapy for patients with advanced pancreatic cancer. Journal of translational medicine.
2007;5:60.
144. Liau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, et al. Dendritic cell
vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the
local central nervous system tumor microenvironment. Clinical cancer research : an official journal of
the American Association for Cancer Research. 2005;11:5515-25.
145. Olivares J, Kumar P, Yu Y, Maples PB, Senzer N, Bedell C, et al. Phase I trial of TGF-beta 2
antisense GM-CSF gene-modified autologous tumor cell (TAG) vaccine. Clinical cancer research : an
official journal of the American Association for Cancer Research. 2011;17:183-92.
146. Yamamoto K, Ueno T, Kawaoka T, Hazama S, Fukui M, Suehiro Y, et al. MUC1 peptide
vaccination in patients with advanced pancreas or biliary tract cancer. Anticancer research.
2005;25:3575-9.
147. Gulley JL, Arlen PM, Tsang KY, Yokokawa J, Palena C, Poole DJ, et al. Pilot study of vaccination
with recombinant CEA-MUC-1-TRICOM poxviral-based vaccines in patients with metastatic carcinoma.
Clinical cancer research : an official journal of the American Association for Cancer Research.
2008;14:3060-9.
148. Morse MA, Clay TM, Hobeika AC, Osada T, Khan S, Chui S, et al. Phase I study of immunization
with dendritic cells modified with fowlpox encoding carcinoembryonic antigen and costimulatory
molecules. Clinical cancer research : an official journal of the American Association for Cancer Research.
2005;11:3017-24.
149. Abdel-Wahab Z, Weltz C, Hester D, Pickett N, Vervaert C, Barber JR, et al. A Phase I clinical trial
of immunotherapy with interferon-gamma gene-modified autologous melanoma cells: monitoring the
humoral immune response. Cancer. 1997;80:401-12.
150. Waterston AM, Gumbrell L, Bratt T, Waller S, Gustav-Aspland J, L'Hermenier C, et al. Phase I
study of TNFalpha AutoVaccIne in patients with metastatic cancer. Cancer immunology, immunotherapy
: CII. 2005;54:848-57.
151. Lubaroff DM, Konety BR, Link B, Gerstbrein J, Madsen T, Shannon M, et al. Phase I clinical trial of
an adenovirus/prostate-specific antigen vaccine for prostate cancer: safety and immunologic results.
Clinical cancer research : an official journal of the American Association for Cancer Research.
2009;15:7375-80.
152. Linette GP, Zhang D, Hodi FS, Jonasch EP, Longerich S, Stowell CP, et al. Immunization using
autologous dendritic cells pulsed with the melanoma-associated antigen gp100-derived G280-9V
peptide elicits CD8+ immunity. Clinical cancer research : an official journal of the American Association
for Cancer Research. 2005;11:7692-9.
Supplemental Table 1. A full list of the analyzed trials.
153. Wittig B, Marten A, Dorbic T, Weineck S, Min H, Niemitz S, et al. Therapeutic vaccination against
metastatic carcinoma by expression-modulated and immunomodified autologous tumor cells: a first
clinical phase I/II trial. Human gene therapy. 2001;12:267-78.
154. Yamamoto K, Mine T, Katagiri K, Suzuki N, Kawaoka T, Ueno T, et al. Immunological evaluation of
personalized peptide vaccination for patients with pancreatic cancer. Oncology reports. 2005;13:874-83.
155. Adamina M, Rosenthal R, Weber WP, Frey DM, Viehl CT, Bolli M, et al. Intranodal immunization
with a vaccinia virus encoding multiple antigenic epitopes and costimulatory molecules in metastatic
melanoma. Molecular therapy : the journal of the American Society of Gene Therapy. 2010;18:651-9.
156. Caruso DA, Orme LM, Amor GM, Neale AM, Radcliff FJ, Downie P, et al. Results of a Phase I study
utilizing monocyte-derived dendritic cells pulsed with tumor RNA in children with Stage 4
neuroblastoma. Cancer. 2005;103:1280-91.
157. Meijer SL, Dols A, Urba WJ, Hu HM, Smith IJ, Vetto J, et al. Adoptive cellular therapy with tumor
vaccine draining lymph node lymphocytes after vaccination with HLA-B7/beta2-microglobulin genemodified autologous tumor cells. J Immunother. 2002;25:359-72.
158. Hueman MT, Dehqanzada ZA, Novak TE, Gurney JM, Woll MM, Ryan GB, et al. Phase I clinical
trial of a HER-2/neu peptide (E75) vaccine for the prevention of prostate-specific antigen recurrence in
high-risk prostate cancer patients. Clinical cancer research : an official journal of the American
Association for Cancer Research. 2005;11:7470-9.
159. Hawkins RE, Macdermott C, Shablak A, Hamer C, Thistlethwaite F, Drury NL, et al. Vaccination of
patients with metastatic renal cancer with modified vaccinia Ankara encoding the tumor antigen 5T4
(TroVax) given alongside interferon-alpha. J Immunother. 2009;32:424-9.
160. Morse MA, Garst J, Osada T, Khan S, Hobeika A, Clay TM, et al. A phase I study of dexosome
immunotherapy in patients with advanced non-small cell lung cancer. Journal of translational medicine.
2005;3:9.
161. Mahvi DM, Shi FS, Yang NS, Weber S, Hank J, Albertini M, et al. Immunization by particlemediated transfer of the granulocyte-macrophage colony-stimulating factor gene into autologous tumor
cells in melanoma or sarcoma patients: report of a phase I/IB study. Human gene therapy.
2002;13:1711-21.
162. Kruit WH, van Ojik HH, Brichard VG, Escudier B, Dorval T, Dreno B, et al. Phase 1/2 study of
subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with
detectable metastatic melanoma. International journal of cancer Journal international du cancer.
2005;117:596-604.
163. Dangoor A, Lorigan P, Keilholz U, Schadendorf D, Harris A, Ottensmeier C, et al. Clinical and
immunological responses in metastatic melanoma patients vaccinated with a high-dose poly-epitope
vaccine. Cancer immunology, immunotherapy : CII. 2010;59:863-73.
164. Yamanaka R, Homma J, Yajima N, Tsuchiya N, Sano M, Kobayashi T, et al. Clinical evaluation of
dendritic cell vaccination for patients with recurrent glioma: results of a clinical phase I/II trial. Clinical
cancer research : an official journal of the American Association for Cancer Research. 2005;11:4160-7.
165. Soiffer R, Hodi FS, Haluska F, Jung K, Gillessen S, Singer S, et al. Vaccination with irradiated,
autologous melanoma cells engineered to secrete granulocyte-macrophage colony-stimulating factor by
adenoviral-mediated gene transfer augments antitumor immunity in patients with metastatic
melanoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
2003;21:3343-50.
166. Seledtsov VI, Shishkov AA, Surovtseva MA, Samarin DM, Seledtsova GV, Niza NA, et al.
Xenovaccinotherapy for melanoma. European journal of dermatology : EJD. 2006;16:655-61.
Supplemental Table 1. A full list of the analyzed trials.
167. Kimball KJ, Preuss MA, Barnes MN, Wang M, Siegal GP, Wan W, et al. A phase I study of a
tropism-modified conditionally replicative adenovirus for recurrent malignant gynecologic diseases.
Clinical cancer research : an official journal of the American Association for Cancer Research.
2010;16:5277-87.
168. Burgdorf SK, Fischer A, Claesson MH, Kirkin AF, Dzhandzhugazyan KN, Rosenberg J. Vaccination
with melanoma lysate-pulsed dendritic cells, of patients with advanced colorectal carcinoma: report
from a phase I study. Journal of experimental & clinical cancer research : CR. 2006;25:201-6.
169. Salgia R, Lynch T, Skarin A, Lucca J, Lynch C, Jung K, et al. Vaccination with irradiated autologous
tumor cells engineered to secrete granulocyte-macrophage colony-stimulating factor augments
antitumor immunity in some patients with metastatic non-small-cell lung carcinoma. Journal of clinical
oncology : official journal of the American Society of Clinical Oncology. 2003;21:624-30.
170. Palefsky JM, Berry JM, Jay N, Krogstad M, Da Costa M, Darragh TM, et al. A trial of SGN-00101
(HspE7) to treat high-grade anal intraepithelial neoplasia in HIV-positive individuals. Aids. 2006;20:11515.
171. Pantuck AJ, van Ophoven A, Gitlitz BJ, Tso CL, Acres B, Squiban P, et al. Phase I trial of antigenspecific gene therapy using a recombinant vaccinia virus encoding MUC-1 and IL-2 in MUC-1-positive
patients with advanced prostate cancer. J Immunother. 2004;27:240-53.
172. Lesimple T, Neidhard EM, Vignard V, Lefeuvre C, Adamski H, Labarriere N, et al. Immunologic
and clinical effects of injecting mature peptide-loaded dendritic cells by intralymphatic and intranodal
routes in metastatic melanoma patients. Clinical cancer research : an official journal of the American
Association for Cancer Research. 2006;12:7380-8.
173. Nemunaitis J, Sterman D, Jablons D, Smith JW, 2nd, Fox B, Maples P, et al. Granulocytemacrophage colony-stimulating factor gene-modified autologous tumor vaccines in non-small-cell lung
cancer. Journal of the National Cancer Institute. 2004;96:326-31.
174. Kitano S, Kageyama S, Nagata Y, Miyahara Y, Hiasa A, Naota H, et al. HER2-specific T-cell immune
responses in patients vaccinated with truncated HER2 protein complexed with nanogels of cholesteryl
pullulan. Clinical cancer research : an official journal of the American Association for Cancer Research.
2006;12:7397-405.
175. Marshall JL, Gulley JL, Arlen PM, Beetham PK, Tsang KY, Slack R, et al. Phase I study of sequential
vaccinations with fowlpox-CEA(6D)-TRICOM alone and sequentially with vaccinia-CEA(6D)-TRICOM, with
and without granulocyte-macrophage colony-stimulating factor, in patients with carcinoembryonic
antigen-expressing carcinomas. Journal of clinical oncology : official journal of the American Society of
Clinical Oncology. 2005;23:720-31.
176. Thomas-Kaskel AK, Zeiser R, Jochim R, Robbel C, Schultze-Seemann W, Waller CF, et al.
Vaccination of advanced prostate cancer patients with PSCA and PSA peptide-loaded dendritic cells
induces DTH responses that correlate with superior overall survival. International journal of cancer
Journal international du cancer. 2006;119:2428-34.
177. Nemunaitis J, Jahan T, Ross H, Sterman D, Richards D, Fox B, et al. Phase 1/2 trial of autologous
tumor mixed with an allogeneic GVAX vaccine in advanced-stage non-small-cell lung cancer. Cancer gene
therapy. 2006;13:555-62.
178. Bernhardt SL, Gjertsen MK, Trachsel S, Moller M, Eriksen JA, Meo M, et al. Telomerase peptide
vaccination of patients with non-resectable pancreatic cancer: A dose escalating phase I/II study. British
journal of cancer. 2006;95:1474-82.
179. Galanis E, Hartmann LC, Cliby WA, Long HJ, Peethambaram PP, Barrette BA, et al. Phase I trial of
intraperitoneal administration of an oncolytic measles virus strain engineered to express
carcinoembryonic antigen for recurrent ovarian cancer. Cancer research. 2010;70:875-82.
Supplemental Table 1. A full list of the analyzed trials.
180. Kuwabara K, Nishishita T, Morishita M, Oyaizu N, Yamashita S, Kanematsu T, et al. Results of a
phase I clinical study using dendritic cell vaccinations for thyroid cancer. Thyroid : official journal of the
American Thyroid Association. 2007;17:53-8.
181. Mavroudis D, Bolonakis I, Cornet S, Myllaki G, Kanellou P, Kotsakis A, et al. A phase I study of the
optimized cryptic peptide TERT(572y) in patients with advanced malignancies. Oncology. 2006;70:30614.
182. Safdar A, Rodriguez MA, Fayad LE, Rodriguez GH, Pro B, Wang M, et al. Dose-related safety and
immunogenicity of baculovirus-expressed trivalent influenza vaccine: a double-blind, controlled trial in
adult patients with non-Hodgkin B cell lymphoma. J Infect Dis. 2006;194:1394-7.
183. Morse MA, Hobeika A, Osada T, Niedzwiecki D, Marcom PK, Blackwell KL, et al. Long term
disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer
following vaccination against Her2. Journal of translational medicine. 2007;5:42.
184. Morita S, Oka Y, Tsuboi A, Kawakami M, Maruno M, Izumoto S, et al. A phase I/II trial of a WT1
(Wilms' tumor gene) peptide vaccine in patients with solid malignancy: safety assessment based on the
phase I data. Japanese journal of clinical oncology. 2006;36:231-6.
185. Dohnal AM, Witt V, Hugel H, Holter W, Gadner H, Felzmann T. Phase I study of tumor Ag-loaded
IL-12 secreting semi-mature DC for the treatment of pediatric cancer. Cytotherapy. 2007;9:755-70.
186. DiPaola RS, Plante M, Kaufman H, Petrylak DP, Israeli R, Lattime E, et al. A phase I trial of pox
PSA vaccines (PROSTVAC-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM) in
patients with prostate cancer. Journal of translational medicine. 2006;4:1.
187. Kavanagh B, Ko A, Venook A, Margolin K, Zeh H, Lotze M, et al. Vaccination of metastatic
colorectal cancer patients with matured dendritic cells loaded with multiple major histocompatibility
complex class I peptides. J Immunother. 2007;30:762-72.
188. Bins A, Mallo H, Sein J, van den Bogaard C, Nooijen W, Vyth-Dreese F, et al. Phase I clinical study
with multiple peptide vaccines in combination with tetanus toxoid and GM-CSF in advanced-stage HLAA*0201-positive melanoma patients. J Immunother. 2007;30:234-9.
189. Ovali E, Dikmen T, Sonmez M, Yilmaz M, Unal A, Dalbasti T, et al. Active immunotherapy for
cancer patients using tumor lysate pulsed dendritic cell vaccine: a safety study. Journal of experimental
& clinical cancer research : CR. 2007;26:209-14.
190. Sabbatini PJ, Ragupathi G, Hood C, Aghajanian CA, Juretzka M, Iasonos A, et al. Pilot study of a
heptavalent vaccine-keyhole limpet hemocyanin conjugate plus QS21 in patients with epithelial ovarian,
fallopian tube, or peritoneal cancer. Clinical cancer research : an official journal of the American
Association for Cancer Research. 2007;13:4170-7.
191. von Euw EM, Barrio MM, Furman D, Levy EM, Bianchini M, Peguillet I, et al. A phase I clinical
study of vaccination of melanoma patients with dendritic cells loaded with allogeneic apoptotic/necrotic
melanoma cells. Analysis of toxicity and immune response to the vaccine and of IL-10 -1082 promoter
genotype as predictor of disease progression. Journal of translational medicine. 2008;6:6.
192. Meyer RG, Korn S, Micke P, Becker K, Huber C, Wolfel T, et al. An open-label, prospective phase
I/II study evaluating the immunogenicity and safety of a ras peptide vaccine plus GM-CSF in patients
with non-small cell lung cancer. Lung Cancer. 2007;58:88-94.
193. Butterfield LH, Comin-Anduix B, Vujanovic L, Lee Y, Dissette VB, Yang JQ, et al. Adenovirus
MART-1-engineered autologous dendritic cell vaccine for metastatic melanoma. J Immunother.
2008;31:294-309.
194. Kenter GG, Welters MJ, Valentijn AR, Lowik MJ, Berends-van der Meer DM, Vloon AP, et al.
Phase I immunotherapeutic trial with long peptides spanning the E6 and E7 sequences of high-risk
human papillomavirus 16 in end-stage cervical cancer patients shows low toxicity and robust
Supplemental Table 1. A full list of the analyzed trials.
immunogenicity. Clinical cancer research : an official journal of the American Association for Cancer
Research. 2008;14:169-77.
195. Santin AD, Bellone S, Palmieri M, Zanolini A, Ravaggi A, Siegel ER, et al. Human papillomavirus
type 16 and 18 E7-pulsed dendritic cell vaccination of stage IB or IIA cervical cancer patients: a phase I
escalating-dose trial. Journal of virology. 2008;82:1968-79.
196. Chianese-Bullock KA, Irvin WP, Jr., Petroni GR, Murphy C, Smolkin M, Olson WC, et al. A
multipeptide vaccine is safe and elicits T-cell responses in participants with advanced stage ovarian
cancer. J Immunother. 2008;31:420-30.
197. Sampson JH, Archer GE, Mitchell DA, Heimberger AB, Herndon JE, 2nd, Lally-Goss D, et al. An
epidermal growth factor receptor variant III-targeted vaccine is safe and immunogenic in patients with
glioblastoma multiforme. Molecular cancer therapeutics. 2009;8:2773-9.
198. Tsuruma T, Iwayama Y, Ohmura T, Katsuramaki T, Hata F, Furuhata T, et al. Clinical and
immunological evaluation of anti-apoptosis protein, survivin-derived peptide vaccine in phase I clinical
study for patients with advanced or recurrent breast cancer. Journal of translational medicine.
2008;6:24.
199. Van Driessche A, Van de Velde AL, Nijs G, Braeckman T, Stein B, De Vries JM, et al. Clinical-grade
manufacturing of autologous mature mRNA-electroporated dendritic cells and safety testing in acute
myeloid leukemia patients in a phase I dose-escalation clinical trial. Cytotherapy. 2009;11:653-68.
200. Perales MA, Yuan J, Powel S, Gallardo HF, Rasalan TS, Gonzalez C, et al. Phase I/II study of GMCSF DNA as an adjuvant for a multipeptide cancer vaccine in patients with advanced melanoma.
Molecular therapy : the journal of the American Society of Gene Therapy. 2008;16:2022-9.
201. Trepiakas R, Berntsen A, Hadrup SR, Bjorn J, Geertsen PF, Straten PT, et al. Vaccination with
autologous dendritic cells pulsed with multiple tumor antigens for treatment of patients with malignant
melanoma: results from a phase I/II trial. Cytotherapy. 2010;12:721-34.
202. Holmes JP, Benavides LC, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, et al. Results of
the first phase I clinical trial of the novel II-key hybrid preventive HER-2/neu peptide (AE37) vaccine.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2008;26:342633.
203. Frank MO, Kaufman J, Tian S, Suarez-Farinas M, Parveen S, Blachere NE, et al. Harnessing
naturally occurring tumor immunity: a clinical vaccine trial in prostate cancer. PloS one. 2010;5.
204. Rezvani K, Yong AS, Mielke S, Savani BN, Musse L, Superata J, et al. Leukemia-associated
antigen-specific T-cell responses following combined PR1 and WT1 peptide vaccination in patients with
myeloid malignancies. Blood. 2008;111:236-42.
205. Okada H, Kalinski P, Ueda R, Hoji A, Kohanbash G, Donegan TE, et al. Induction of CD8+ T-cell
responses against novel glioma-associated antigen peptides and clinical activity by vaccinations with
{alpha}-type 1 polarized dendritic cells and polyinosinic-polycytidylic acid stabilized by lysine and
carboxymethylcellulose in patients with recurrent malignant glioma. Journal of clinical oncology : official
journal of the American Society of Clinical Oncology. 2011;29:330-6.
206. Slingluff CL, Jr., Petroni GR, Olson W, Czarkowski A, Grosh WW, Smolkin M, et al. Helper T-cell
responses and clinical activity of a melanoma vaccine with multiple peptides from MAGE and
melanocytic differentiation antigens. Journal of clinical oncology : official journal of the American
Society of Clinical Oncology. 2008;26:4973-80.
207. Rosenblatt J, Vasir B, Uhl L, Blotta S, Macnamara C, Somaiya P, et al. Vaccination with dendritic
cell/tumor fusion cells results in cellular and humoral antitumor immune responses in patients with
multiple myeloma. Blood. 2011;117:393-402.
Supplemental Table 1. A full list of the analyzed trials.
208. Diefenbach CS, Gnjatic S, Sabbatini P, Aghajanian C, Hensley ML, Spriggs DR, et al. Safety and
immunogenicity study of NY-ESO-1b peptide and montanide ISA-51 vaccination of patients with
epithelial ovarian cancer in high-risk first remission. Clinical cancer research : an official journal of the
American Association for Cancer Research. 2008;14:2740-8.
209. Haining WN, Cardoso AA, Keczkemethy HL, Fleming M, Neuberg D, DeAngelo DJ, et al. Failure to
define window of time for autologous tumor vaccination in patients with newly diagnosed or relapsed
acute lymphoblastic leukemia. Experimental hematology. 2005;33:286-94.
210. Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, et al. Vaccination with multiple
peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical
responses in advanced esophageal cancer. Cancer science. 2009;100:1502-9.
211. Park JW, Melisko ME, Esserman LJ, Jones LA, Wollan JB, Sims R. Treatment with autologous
antigen-presenting cells activated with the HER-2 based antigen Lapuleucel-T: results of a phase I study
in immunologic and clinical activity in HER-2 overexpressing breast cancer. Journal of clinical oncology :
official journal of the American Society of Clinical Oncology. 2007;25:3680-7.
212. Speetjens FM, Kuppen PJ, Welters MJ, Essahsah F, Voet van den Brink AM, Lantrua MG, et al.
Induction of p53-specific immunity by a p53 synthetic long peptide vaccine in patients treated for
metastatic colorectal cancer. Clinical cancer research : an official journal of the American Association for
Cancer Research. 2009;15:1086-95.
213. Ruttinger D, van den Engel NK, Winter H, Schlemmer M, Pohla H, Grutzner S, et al. Adjuvant
therapeutic vaccination in patients with non-small cell lung cancer made lymphopenic and reconstituted
with autologous PBMC: first clinical experience and evidence of an immune response. Journal of
translational medicine. 2007;5:43.
214. Feyerabend S, Stevanovic S, Gouttefangeas C, Wernet D, Hennenlotter J, Bedke J, et al. Novel
multi-peptide vaccination in Hla-A2+ hormone sensitive patients with biochemical relapse of prostate
cancer. The Prostate. 2009;69:917-27.
215. Peethambaram PP, Melisko ME, Rinn KJ, Alberts SR, Provost NM, Jones LA, et al. A phase I trial
of immunotherapy with lapuleucel-T (APC8024) in patients with refractory metastatic tumors that
express HER-2/neu. Clinical cancer research : an official journal of the American Association for Cancer
Research. 2009;15:5937-44.
216. Timmerman JM, Vose JM, Czerwinski DK, Weng WK, Ingolia D, Mayo M, et al. Tumor-specific
recombinant idiotype immunisation after chemotherapy as initial treatment for follicular non-Hodgkin
lymphoma. Leukemia & lymphoma. 2009;50:37-46.
217. Motohashi S, Nagato K, Kunii N, Yamamoto H, Yamasaki K, Okita K, et al. A phase I-II study of
alpha-galactosylceramide-pulsed IL-2/GM-CSF-cultured peripheral blood mononuclear cells in patients
with advanced and recurrent non-small cell lung cancer. J Immunol. 2009;182:2492-501.
218. Kaumaya PT, Foy KC, Garrett J, Rawale SV, Vicari D, Thurmond JM, et al. Phase I active
immunotherapy with combination of two chimeric, human epidermal growth factor receptor 2, B-cell
epitopes fused to a promiscuous T-cell epitope in patients with metastatic and/or recurrent solid
tumors. Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
2009;27:5270-7.
219. Um SJ, Choi YJ, Shin HJ, Son CH, Park YS, Roh MS, et al. Phase I study of autologous dendritic cell
tumor vaccine in patients with non-small cell lung cancer. Lung Cancer. 2010;70:188-94.
220. Giannopoulos K, Dmoszynska A, Kowal M, Rolinski J, Gostick E, Price DA, et al. Peptide
vaccination elicits leukemia-associated antigen-specific cytotoxic CD8+ T-cell responses in patients with
chronic lymphocytic leukemia. Leukemia. 2010;24:798-805.
Supplemental Table 1. A full list of the analyzed trials.
221. Perroud MW, Jr., Honma HN, Barbeiro AS, Gilli SC, Almeida MT, Vassallo J, et al. Mature
autologous dendritic cell vaccines in advanced non-small cell lung cancer: a phase I pilot study. Journal
of experimental & clinical cancer research : CR. 2011;30:65.
222. Wiedermann U, Wiltschke C, Jasinska J, Kundi M, Zurbriggen R, Garner-Spitzer E, et al. A
virosomal formulated Her-2/neu multi-peptide vaccine induces Her-2/neu-specific immune responses in
patients with metastatic breast cancer: a phase I study. Breast cancer research and treatment.
2010;119:673-83.
223. Pandha HS, John RJ, Hutchinson J, James N, Whelan M, Corbishley C, et al. Dendritic cell
immunotherapy for urological cancers using cryopreserved allogeneic tumour lysate-pulsed cells: a
phase I/II study. BJU international. 2004;94:412-8.
224. Kowalski M, Entwistle J, Cizeau J, Niforos D, Loewen S, Chapman W, et al. A Phase I study of an
intravesically administered immunotoxin targeting EpCAM for the treatment of nonmuscle-invasive
bladder cancer in BCGrefractory and BCG-intolerant patients. Drug design, development and therapy.
2010;4:313-20.
225. Katano M, Morisaki T, Koga K, Nakamura M, Onishi H, Matsumoto K, et al. Combination therapy
with tumor cell-pulsed dendritic cells and activated lymphocytes for patients with disseminated
carcinomas. Anticancer research. 2005;25:3771-6.
226. Perez SA, Kallinteris NL, Bisias S, Tzonis PK, Georgakopoulou K, Varla-Leftherioti M, et al. Results
from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients
with prostate cancer. Clinical cancer research : an official journal of the American Association for Cancer
Research. 2010;16:3495-506.
227. Banchereau J, Ueno H, Dhodapkar M, Connolly J, Finholt JP, Klechevsky E, et al. Immune and
clinical outcomes in patients with stage IV melanoma vaccinated with peptide-pulsed dendritic cells
derived from CD34+ progenitors and activated with type I interferon. J Immunother. 2005;28:505-16.
228. Carmichael MG, Benavides LC, Holmes JP, Gates JD, Mittendorf EA, Ponniah S, et al. Results of
the first phase 1 clinical trial of the HER-2/neu peptide (GP2) vaccine in disease-free breast cancer
patients: United States Military Cancer Institute Clinical Trials Group Study I-04. Cancer. 2010;116:292301.
229. Loveland BE, Zhao A, White S, Gan H, Hamilton K, Xing PX, et al. Mannan-MUC1-pulsed dendritic
cell immunotherapy: a phase I trial in patients with adenocarcinoma. Clinical cancer research : an official
journal of the American Association for Cancer Research. 2006;12:869-77.
230. Speiser DE, Schwarz K, Baumgaertner P, Manolova V, Devevre E, Sterry W, et al. Memory and
effector CD8 T-cell responses after nanoparticle vaccination of melanoma patients. J Immunother.
2010;33:848-58.
231. Curti A, Tosi P, Comoli P, Terragna C, Ferri E, Cellini C, et al. Phase I/II clinical trial of sequential
subcutaneous and intravenous delivery of dendritic cell vaccination for refractory multiple myeloma
using patient-specific tumour idiotype protein or idiotype (VDJ)-derived class I-restricted peptides.
British journal of haematology. 2007;139:415-24.
232. Baba T, Sato-Matsushita M, Kanamoto A, Itoh A, Oyaizu N, Inoue Y, et al. Phase I clinical trial of
the vaccination for the patients with metastatic melanoma using gp100-derived epitope peptide
restricted to HLA-A*2402. Journal of translational medicine. 2010;8:84.
233. Prins RM, Soto H, Konkankit V, Odesa SK, Eskin A, Yong WH, et al. Gene expression profile
correlates with T-cell infiltration and relative survival in glioblastoma patients vaccinated with dendritic
cell immunotherapy. Clinical cancer research : an official journal of the American Association for Cancer
Research. 2011;17:1603-15.
Supplemental Table 1. A full list of the analyzed trials.
234. Weber JS, Vogelzang NJ, Ernstoff MS, Goodman OB, Cranmer LD, Marshall JL, et al. A phase 1
study of a vaccine targeting preferentially expressed antigen in melanoma and prostate-specific
membrane antigen in patients with advanced solid tumors. J Immunother. 2011;34:556-67.
235. Karbach J, Neumann A, Atmaca A, Wahle C, Brand K, von Boehmer L, et al. Efficient in vivo
priming by vaccination with recombinant NY-ESO-1 protein and CpG in antigen naive prostate cancer
patients. Clinical cancer research : an official journal of the American Association for Cancer Research.
2011;17:861-70.
236. Terasaki M, Shibui S, Narita Y, Fujimaki T, Aoki T, Kajiwara K, et al. Phase I trial of a personalized
peptide vaccine for patients positive for human leukocyte antigen--A24 with recurrent or progressive
glioblastoma multiforme. Journal of clinical oncology : official journal of the American Society of Clinical
Oncology. 2011;29:337-44.
237. Krug LM, Ragupathi G, Hood C, George C, Hong F, Shen R, et al. Immunization with N-propionyl
polysialic acid-KLH conjugate in patients with small cell lung cancer is safe and induces IgM antibodies
reactive with SCLC cells and bactericidal against group B meningococci. Cancer immunology,
immunotherapy : CII. 2011.
238. Kakimi K, Isobe M, Uenaka A, Wada H, Sato E, Doki Y, et al. A phase I study of vaccination with
NY-ESO-1f peptide mixed with Picibanil OK-432 and Montanide ISA-51 in patients with cancers
expressing the NY-ESO-1 antigen. International journal of cancer Journal international du cancer.
2011;129:2836-46.
239. Oka Y, Tsuboi A, Taguchi T, Osaki T, Kyo T, Nakajima H, et al. Induction of WT1 (Wilms' tumor
gene)-specific cytotoxic T lymphocytes by WT1 peptide vaccine and the resultant cancer regression.
Proceedings of the National Academy of Sciences of the United States of America. 2004;101:13885-90.
240. Ramanathan RK, Lee KM, McKolanis J, Hitbold E, Schraut W, Moser AJ, et al. Phase I study of a
MUC1 vaccine composed of different doses of MUC1 peptide with SB-AS2 adjuvant in resected and
locally advanced pancreatic cancer. Cancer immunology, immunotherapy : CII. 2005;54:254-64.
241. Ramos TC, Vinageras EN, Ferrer MC, Verdecia BG, Rupale IL, Perez LM, et al. Treatment of NSCLC
patients with an EGF-based cancer vaccine: report of a Phase I trial. Cancer biology & therapy.
2006;5:145-9.
242. Di Pucchio T, Pilla L, Capone I, Ferrantini M, Montefiore E, Urbani F, et al. Immunization of stage
IV melanoma patients with Melan-A/MART-1 and gp100 peptides plus IFN-alpha results in the activation
of specific CD8(+) T cells and monocyte/dendritic cell precursors. Cancer research. 2006;66:4943-51.
243. Bender A, Karbach J, Neumann A, Jager D, Al-Batran SE, Atmaca A, et al. LUD 00-009: phase 1
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244. Odunsi K, Qian F, Matsuzaki J, Mhawech-Fauceglia P, Andrews C, Hoffman EW, et al. Vaccination
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