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Current Clinical Trials in Non-Hodgkin’s Lymphoma
Published on Cancer Network (http://www.cancernetwork.com)
Current Clinical Trials in Non-Hodgkin’s Lymphoma
Review Article [1] | June 01, 2002
By Bruce D. Cheson, MD [2]
The non-Hodgkin’s lymphomas (NHL) are the fifth most common cause of cancer in men and women
in the United States, and the fifth and sixth leading causes of cancer deaths, respectively.
Approximately 54,000 new cases are projected to be diagnosed in the United States this year,[1]
25% to 30% of which are indolent histologies, with the remainder being aggressive tumors.
he non-Hodgkin’s lymphomas (NHL) are the fifth most common cause of cancer in men and women
in the United States, and the fifth and sixth leading causes of cancer deaths, respectively.
Approximately 54,000 new cases are projected to be diagnosed in the United States this year,[1]
25% to 30% of which are indolent histologies, with the remainder being aggressive tumors.
T
Clinical Trials Referral Resource is designed to serve as a ready reference for oncologists to help
identify clinical trials that might be suitable for their patients. We hope it will also enhance accrual to
clinical trials by informing practicing oncologists of ongoing protocols. Currently in the United States
less than 10% of eligible adult patients are entered into clinical trials. The result is a delay in
answering important therapeutic and scientific questions and disseminating therapeutic advances to
the general oncology community.
It should be emphasized that including a specific trial does not imply that it is more important than
another trial. Among the criteria for selection are that the trial is addressing an important question
and is not expected to close in the immediate future (less than 1 year), and that initial staging or
laboratory tests required for patient eligibility are widely practiced and available. Information on
other protocols can be accessed via Physician’s Data Query (PDQ).*
We emphasize that this is an attempt to encourage referral of patients to these trials. We are
specifically not soliciting additional members for the cooperative groups, nor are we suggesting how
practicing oncologists should be treating patients who are not in a study.
This month’s installment of Clinical Trials Referral Resource is devoted to current clinical trials in
non-Hodgkin's lymphoma.
For patient entry information, see the individual trials.
* PDQ is a comprehensive database service provided by the National Cancer Institute’s International Cancer Information Center and Office of Cancer Communications for retrieval of cancer treatment information, including peer-reviewed statements on treatment options, supportive care, screening, and prevention; and an international clinical trials registry. For more information on PDQ, online access is available at www.cancer.gov/cancer_information/pdq/, or contact the Cancer Information Service offices (1-800-4-CANCER).
After decades of limited progress in the therapy of these disorders, therapeutic paradigms have
undergone a revolution. This monumental change is clearly the result of the availability of rituximab
(Rituxan), the first monoclonal antibody approved for the treatment of a human malignancy.[2,3]
However, fewer than half of patients with follicular NHL respond to rituximab, and the median
response duration is about 1 year. Potential means of improving on this level of activity may be
afforded by the new generation of radioimmunoconjugates, notably ibritumomab tiuxetan (Zevalin),
recently approved by the Food and Drug Administration (FDA), and tositumomab/iodine-131
tositumomab (Bexxar).[4,5]
Other cytokines, such as interleukin-12 (IL-12), may augment the effector cell mechanisms activated
when rituximab binds to the lymphoma cells.[6] Additional data suggest that bcl-2 antisense can
potentiate the activity of rituximab.[7]
Focus on Targeted Therapies
This month’s Patient Referral Resource in B-cell non-Hodgkin’s lymphomas makes a resounding point
that the current direction of clinical research has moved beyond minor modifications of the dose and
schedule of standard, nonspecific cytotoxic approaches. The current focus is on specific, targeted
therapies. The rational development of new strategies that integrate multiple antibodies directed
against different antigens, cytokines that enhance the activity of those antibodies, antisense
compounds, and new chemotherapy drugs with unique mechanisms of action will hopefully increase
our ability to cure these patients.
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Current Clinical Trials in Non-Hodgkin’s Lymphoma
Published on Cancer Network (http://www.cancernetwork.com)
The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD)
at the National Cancer Institute (NCI) sponsors a variety of trials for patients with newly diagnosed
non-Hodgkin’s lymphoma using a wide range of agents and schedules. The list below includes
approved and/or active clinical trials that are currently being sponsored by the CTEP for the
treatment of non-Hodgkin’s lymphoma. Information about these studies can be obtained from the
principal investigator or contacts listed for each trial or from Bruce Cheson, MD, at CTEP
([email protected]), 301-496-2522.
Phase III
Title: Randomized Trial of Patient-Specific Vaccination with Conjugated Follicular
Lymphoma-Derived Idiotype with Local GM-CSF in First Complete Remission
Protocol Number: NCI-00-C-0050, NCI-9900.v6
Participating Institutions: National Cancer Institute Medicine Branch, Moffitt Cancer Center and
Research Institute, Northwestern University, Duke University Medical Center, University of
Pennsylvania Cancer Center, Bellevue Hospital Center
Contact: Larry W. Kwak, MD, Bethesda, Maryland, (301) 846-1607; for a complete listing of study
contacts, click here
Latest Information: http://www.cancer.gov/clinical_trials/
Title: Randomized Phase III Study in Low-Grade Lymphoma Comparing
Cyclophosphamide-Fludarabine to Standard Therapy Followed by Maintenance Anti-CD20 Antibody
Protocol Number: E1496
Participating Institutions: Eastern Cooperative Oncology Group, Cancer and Leukemia Group B
Contact: Jean McDonald, Coordinator, Brookline, Massachusetts, (617) 632-3610
Title: Phase III Randomized Study of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
(CHOP) With or Without Either Rituximab or Iodine I 131 Tositumomab (Monoclonal Antibody Anti-B1)
in Patients With Newly Diagnosed Follicular Non-Hodgkin's Lymphoma
Protocol Number: CLB-50102, SWOG-S0016
Participating Institutions: Southwest Oncology Group, Southwest Oncology Group CCOP Ordering
Group
Contact: Marjorie Godfrey, Coordinator, San Antonio, Texas, (210) 677-8808; for a complete listing
of study contacts, click here
Latest Information: http://www.cancer.gov/clinical_trials/
Title: Phase III Study of Early High-Dose Chemoradiotherapy and Autologous Peripheral Blood Stem
Cell Transplantation Versus Conventional Dose Cyclophosphamide, Doxorubicin, Vincristine, and
Prednisone (CHOP) in Patients with Intermediate or High Grade Non-Hodgkin's Lymphoma
Protocol Number: CAN-NCIC-LY11, CLB-59903, E-S9704, SWOG-S9704
Participating Institutions: Southwest Oncology Group, Cancer and Leukemia Group B, Eastern
Cooperative Oncology Group, National Cancer Institute of Canada
Contact: Marjorie Godfrey, Coordinator, San Antonio, Texas, (210) 677-8808; for a complete listing
of study contacts, click here
Latest Information: http://www.cancer.gov/clinical_trials/
Phase II
Title: Pilot Study of Idiotype Vaccine and Epoch-Rituximab Chemotherapy in Untreated Mantle Cell
Lymphoma
Protocol Number: 1033
Participating Institution: National Cancer Institute Medicine Branch
Contact: Wyndham H. Wilson, MD, Bethesda, Maryland, (301) 435-2415, [email protected]
Title: Phase II Study of Rituximab and High-Intensity Chemotherapy With Filgrastim (G-CSF) Support
in Patients With Previously Untreated Burkitt's Lymphoma or Burkitt's Leukemia
Protocol Number: CLB-10002
Participating Institution: Cancer and Leukemia Group B
Contact: CALGB Central Office, Chicago, Illinois, (773) 702-9171
Latest Information: http://www.cancer.gov/clinical_trials/
Title: Phase II Study of Rituximab, Doxorubicin, Etoposide, Vincristine, Prednisone, and
Cyclophosphamide in Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's
Lymphoma
Protocol Number: CLB-50103
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Current Clinical Trials in Non-Hodgkin’s Lymphoma
Published on Cancer Network (http://www.cancernetwork.com)
Participating Institution: Cancer and Leukemia Group B
Contact: CALGB Central Office, Chicago, Illinois, (773) 702-9171; for a complete listing of study
contacts, click here
Latest Information: http://www.cancer.gov/clinical_trials/
Title: Phase II Study of Intensive Chemotherapy and Rituximab With Autologous Peripheral Blood
Stem Cell Transplantation in Patients With Mantle Cell Lymphoma
Protocol Number: CLB-59909
Participating Institution: Cancer and Leukemia Group B
Contact: CALGB Central Office, Chicago, Illinois, (773) 702-9171; for a complete listing of study
contacts, click here
Latest Information: http://www.cancer.gov/clinical_trials/
Title: Phase II Randomized Study of Rituximab With or Without Interleukin-12 in Patients With B-Cell
Non-Hodgkin's Lymphoma
Protocol Number: NCCTG-N0087
Participating Institution: North Central Cancer Treatment Group
Contact: Stephen M. Ansell, MD, Rochester, Minnesota, (507) 284-2511, [email protected];
for a complete listing of study contacts, click here
Latest Information: http://www.cancer.gov/clinical_trials/
Title: Phase II Study of High Dose Cytarabine/Methotrexate and High Dose
Cyclophosphamide/Dexamethasone/Doxorubicin/Vincristine (HCVAD) in Patients with Newly
Diagnosed Diffuse and Nodular Mantle Cell Lymphoma
Protocol Number: MDA-DM-97200, NCI-T97-0101
Participating Institution: M. D. Anderson Cancer Center
Contact: Jorge E. Romaguera, MD, Houston, Texas, (713) 792-2933
Latest Information: http://www.cancer.gov/clinical_trials/
Phase I/II
Title: Phase II Study of Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin
(EPOCH) With Rituximab and Filgrastim (G-CSF) in Patients With Stage I-IV Non-Hodgkin's Lymphoma
Protocol Number: CRB-9307, NCI-93-C-0133L, NCI-MB-303, NCI-T93-0023N
Participating Institutions: National Cancer Institute Medicine Branch, Biological Response
Modifiers Program, Massachusetts General Hospital, University of Maryland Cancer Center, Holy
Cross Hospital
Contact: Wyndham H. Wilson, MD, Bethesda, Maryland, (301) 435-2415, [email protected]
Latest Information: http://www.cancer.gov/clinical_trials/
Phase I
Title: Phase I Study of Rituximab Followed by Interleukin-2 in Patients With CD20-Positive B-Cell
Lymphoid Malignancy
Protocol Number: NCI-130, OSU-0037, OSU-00H0223
Participating Institution: Ohio State University Hospital
Contact: Pierluigi Porcu, MD, Columbus, Ohio, (614) 293-4275, [email protected]
Latest Information: http://www.cancer.gov/clinical_trials/
Title: Phase I Study of Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, and Autologous Peripheral
Blood Stem Cell Rescue in Patients With Indolent Non-Hodgkin's Lymphoma
Protocol Number: JHOC-J0004, NCI-970
Participating Institutions: Johns Hopkins University, Moffitt Cancer Center and Research Institute,
Ohio State University Hospital
Contact: Ian W. Flinn, MD, Baltimore, Maryland, (410) 955-8781, [email protected]
Latest Information: http://www.cancer.gov/clinical_trials/
References:
1. Jemal A, Thomas A, Murray T, et al: Cancer statistics: 2002. CA Cancer J Clin 52:23-47, 2002.
2. McLaughlin P, Grillo-López AJ, Link BK, et al: Rituximab chimeric anti-CD20 monoclonal antibody
therapy of relapsed indolent lymphoma: Half of patients respond to a four-dose treatment program. J
Clin Oncol 16:2825-2833, 1998.
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Current Clinical Trials in Non-Hodgkin’s Lymphoma
Published on Cancer Network (http://www.cancernetwork.com)
3. Cheson BD: Rituximab: Clinical development and future directions. Expert Opin Biol Ther 2:97-110,
2002.
4. Witzig TE, White CA, Gordon LI, et al: Final results of a randomized controlled study of the Zevalin
radioimmunotherapy regimen vs a standard course of rituximab immunotherapy for B-cell NHL
(abstract 3591). Blood 96:831a, 2000.
5. Kaminski MS, Zelenetz AD, Press OW, et al: Pivotal study of Bexxar (Iodine I131 tositumomab) for
chemotherapy-refractory low-grade or transformed low-grade B-cell non-Hodgkin’s lymphomas. J Clin
Oncol 19:3918-3928, 2001.
6. Ansell SM, Witzig TE, Kurtin PJ, et al: Phase I study of interleukin-12 in combination with rituximab
in patients with B-cell non-Hodgkin’s lymphoma. Blood 99:67-74, 2002.
7. Auer RL, Corbo M, Fegan CD, et al: Bcl-2 antisense (Genasense) induces apoptosis and potentiates
activity of both cytotoxic chemotherapy and rituximab in primary CLL cells (abstract 3358). Blood
98:808a, 2001.
Source URL:
http://www.cancernetwork.com/review-article/current-clinical-trials-non-hodgkin%E2%80%99s-lymph
oma
Links:
[1] http://www.cancernetwork.com/review-article
[2] http://www.cancernetwork.com/authors/bruce-d-cheson-md
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