Download Open Trials List - Penn State Hershey

OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
ADULT TRIALS
THERAPEUTIC
Protocol No.
Title
CRC
BRAIN
Wagner, Henry
PSHCI-10-026
Aergawi, Dawit
PSHCI-15-081
Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis Coordinated
by the Radiation Therapy Oncology Group (RTOG 0631)
An Open-Label, Single-Arm, Phase II Study of Pertuzumab with High-Dose Trastuzumab for the
Treatment of Central Nervous System Progression Post-Radiotherapy in Patients with HER2-Positive
Metastatic Breast Cancer (PATRICIA)
Aergawi, Dawit
PSHCI-16-016
A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 With Concurrent Chemoradiation
and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Cynthia Campbell-Baird, 717Growth Factor Receptor (EGFR) Amplification (Intellance 1)
531-5777 & pager 1738
Aergawi, Dawit
PSCI-16-062
Black, David
PSCI-16-064
A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide
(TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy
NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in
Adults
Kathleen Rizzo 717-5310003 ext 289630
Cynthia Campbell-Baird, 717531-5777 & pager 1738
Nikita Shah 717-531-0003
ext 282645
Nicole Matthews 717-5316069
BREAST
4/25/2017
Truica, Cristina
PSHCI-13-002
Truica, Cristina
PSHCI-13-041
Schetter, Susann
PSHCI-13-083
Wagner, Henry
PSHCI-13-084
Truica, Cristina
PSHCI-13-101
Truica, Cristina
PSHCI-14-082
Truica, Cristina
PSHCI-14-103
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine
Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and
HER2/NEU Negative Breast Cancer (S1207)
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms
(AIMSS) (E1Z11)
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with
Breast Cancer
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal
XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before
Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After
Neoadjuvant Chemotherapy (B-51 and R1304)
Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer
NeoAdjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+
Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the
Metastatic Setting (NALA)
Phase III Study Evaluating Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor
in Patients With Hormone-receptor-positive, HER2-normal Primary Breast Cancer With High Relapse
Risk After Neoadjuvant Chemotherapy "PENELOPEB"
Page 1 of 12
Lea May 717-531-0003 ext
285550 pager 3973
Lea May 717-531-0003 ext
285550 pager 3973
Swati Shah 717-531-6069
Lea May 717-531-0003 ext
285550 pager 3973
Lea May 717-531-0003 ext
285550 pager 3973
Lea May 717-531-0003 ext
285550 pager 3973
Lea May 717-531-0003 ext
285550 pager 3973
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
4/25/2017
Protocol No.
Title
Widders, Kristine
PSHCI-14-105
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in
Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After
Neoadjuvant Chemotherapy (A011202)
Truica, Cristina
PSHCI-14-106
A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Postmenopausal
Patients With Hormone Receptor-Positive Advanced Breast Cancer (E2112)
CRC
Lea May 717-531-0003 ext
285550 pager 3973
Lea May 717-531-0003 ext
285550 pager 3973
Cream, Leah
PSHCI-14-107
Truica, Cristina
PSHCI-15-059
Truica, Cristina
PSHCI-15-060
Truica, Cristina
PSCI-16-031
Truica, Cristina
PSCI-16-053
Truica, Cristina
PSCI-16-055
A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to
Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With
Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have
Lea May 717-531-0003 ext
Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy (OlympiA)
285550 pager 3973
EA1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs.
Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following
Lea May 717-531-0003 ext
Neoadjuvant Chemotherapy
285550 pager 3973
A Randomized Phase III trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide
followed by Weekly Paclitaxel with or without Carboplatin in Women with Node-Positive or High-Risk Lea May 717-531-0003 ext
Node-Negative
Triple Negative
Invastive
Breast
Cancer
285550 pager 3973
PALLAS: PALbociclib
CoLlaborative
Adjuvant
Study:
A Randomized Phase III Trial of Palbociclib
With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for
Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative
Lea May 717-531-0003 ext
Early Breast Cancer
285550 pager 3973
A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for
Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC- Lea May 717-531-0003 ext
BRE15-016
285550 pager 3973
A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus +
Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally
Lea May 717-531-0003 ext
Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor (TRINITI-1)
285550 pager 3973
Truica, Cristina
PSCI-16-067
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight
and Obese Women With Early Breast Cancer
Page 2 of 12
Lea May 717-531-0003 ext
285550 pager 3973
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
CARCINOID SYNDROME
(None as of 04/25/2017)
GI
Moyer, Matthew
PSHCI-10-109
Yee, Nelson Shu-sang
PSHCI-14-032
Glantz, Michael
PSHCI-15-044
Almokadem, Salah
PSHCI-15-105
Yee, Nelson Shu-sang
PSHCI-15-109
Yee, Nelson Shu-sang
PSHCI-15-110
Jia, Yuxia; Schmitz, Kathryn,
H
PSHCI-15-114
4/25/2017
Yee, Nelson Shu-sang
PSHCI-16-025
Jia, Yuxia
PSCI-16-050
Yee, Nelson Shu-sang
PSCI-16-075
Yee, Nelson Shu-sang
PSCI-16-091
Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by
Sorafenib in Hepatocellular Carcinoma
Risk Factors for CIPN Following an Oxaliplatin-Containing Chemotherapy Regimen in Colorectal
Cancer Patients
A Phase III Randomized Open-label Study of Single Agent Pembrolizumab vs Physicians' Choice of
Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic
Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After FirstLine Standard Therapy (KEYNOTE-181)
Matthew Moyer 717-5313694
Kathleen Rizzo 717-5310003 ext 289630
Sara Langan
[email protected]
Jennifer Hallman 717-5310003 ext 287412
Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in
Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And
Genitourinary Tumors
Rebecca Hale 717-5311003 pager 3656
Kathleen Rizzo 717-5310003 ext 289630
Resistance Training to Decrease Chemotoxicity in Colon Cancer Patients
InterAACT - An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer
Trial Comparing Cisplatin Plus 5-Fluorouracil Versus Carboplatin Plus Weekly Paclitaxel in Patients
With Inoperable Locally Recurrent or Metastatic Disease
A Phase III Randomized Placebo-Controlled Study Evaluating Regorafenib Following Completion of
Standard Chemotherapy for Patients With Stage III Colon Cancer
A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of
Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus
Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or
Gastroesophageal Junction (GEJ) Adenocarcinoma
An Open Label Randomized Phase I/II Trial of MLN0128 Compared to Sorafenib in Patients with
Advanced or Metastatic Hepatocellular Carcinoma
Wanda Neidig 717-531-1002
Page 3 of 12
Jennifer Hallman 717-5310003 ext 287412
Kathleen Rizzo 717-5310003 ext 289630
Kathleen Rizzo 717-5310003 ext 289630
Kathleen Rizzo 717-5310003 ext 289630
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
GU
Joshi, Monika
PSHCI-13-090
A Phase III Randomized Trial Comparing Androgen Deprivation
Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in
Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate
Cancer (S1216)
Joshi, Monika
PSHCI-14-040
A Phase 2 Randomized, Double-Blind Study of Dalantercept plus Axitinib Compared to Placebo plus
Axitinib in Patients with Advanced Renal Cell Carcinoma (Acceleron Pharma, Inc)
Joshi, Monika
PSHCI-15-002
Raman, Jay
PSHCI-15-095
Yee, Nelson Shu-sang
PSHCI-15-110
Kaag, Matthew
PSCI-16-048
Joshi, Monika
PSCI-16-059
Joshi, Monika
PSCI-16-096
Aregawi, Dawit
PSCI-16-097
A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two
Different Dose Regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with
Metastatic or Surgically Unresectable Urothelial Cancer with FGFR Genomic Alterations
Evaluation of the ACS NSQIP Surgical Risk Calculator in Patients Undergoing Radical
Nephroureterectomy for Upper Tract TCC
A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And
Genitourinary Tumors
A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-Interferon
(IFN)/Syn3) Administered Intravesically to Patients With High Grade, BCG Unresponsive Non-Muscle
Invasive Bladder Cancer (NMIBC)
Phase Ib/II Study of Concurrent Durvalumab And Radiation Therapy (DUART) Followed by Adjuvant
Durvalumab in Patients with Urothelial Cancer (T2-4 N0-2 M0) of the Bladder:Big Ten Cancer
Research Consortium BTCRC-GU15-023
A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody)
Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial
Carcinoma After Surgical Resection
Phase 1B, Multicenter, Open-Label Study of Marizomib Combined with Temozolomide and
Radiotherapy in Patients with Newly Diagnosed WHO Grade IV Malignant Glioma
Kathleen Rizzo 717-5310003 ext 289630
Kathleen Rizzo 717-5310003 ext 289630
Kathleen Rizzo 717-5310003 ext 289630
JRAMAN@pennstatehealth
.psu.edu
Kathleen Rizzo 717-5310003 ext 289630
Kathleen Rizzo 717-5310003 ext 289630
Kathleen Rizzo 717-5310003 ext 289630
Kathleen Rizzo 717-5310003 ext 289630
Nikita Shah 717-531-0003
ext 282645
GYN
4/25/2017
Kesterson, Joshua
PSHCI-09-064
Kesterson, Joshua
PSHCI-09-073
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in
Combination with Bevacizumab Followed by Bevacizumab and Secondary Cytoreductive Surgery in
Platinum Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer (GOG 213)
A Randomized phase III trial of Cisplatin and Tumor Volume Directed Irradiation Followed by
Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced
Endometrial Carcinoma (GOG 258)
Page 4 of 12
Ann Gelder 717-531-8144
pager 1488
Ann Gelder 717-531-8144
pager 1488
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
HEAD AND NECK
Almokadem, Salah
PSCI-16-128
A Phase II Study OF Enzalutamide (NSC# 766085) for patients with Androgen receptor positive
salivary cancers
Rebecca Hale 717-5311003 pager 3656
Almokadem, Salah
PSCI-17-003
A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and
MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)
Rebecca Hale 717-5311003 pager 3656
HEMATOLOGY/OTHER
Rybka, Witold
PSHCI-13-029
Greiner, Robert, J
PSCI-16-078
A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC) Conditioning and
Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical
Brian Couch 717-531-0003
Related Bone Marrow (Haplo) for Patients with Hematologic Malignancies
ext 285861 pager 0406
A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best
Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
Undergoing Hematopoietic Stem Cell Transplant
COG Contact 717-531-6012
McGregor, Lisa
PSHCI-11-097
A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC#
681239) and Sorafenib (BAY 43-9006,IND#69896, NSC# 724772 for Patients with High Allelic Ratio
FLT3/ITD
Claxton, David
PSHCI-13-097
Claxton, David
PSHCI-13-100
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage
Acute Lymphoblastic Leukemia in Adults
Phase 3 Open-Label Randomized Study of Quizartinib (AC220) Monotherapy
Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia(AML)
Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell
Transplant (HSCT) Consolidation (Ambit Biosciences)
Claxton, David
PSHCI-15-054
A Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Christine Capper, 717-531Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) withFLT3 Mutation
0003 ext 285453
Pu, Jeffrey
PSHCI-15-065
Brown, Valerie
PSHCI-15-075
Palmisiano, Neil
PSHCI-15-093
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib
in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia
A Phase 2, Multi-center, Single-arm, Open-label Study to Evaluate the Activity, Safety and
Pharmacokinetics of Lenalidomide (Revlimid®) in Pediatric Subjects 1 to ≤ 18 Years of Age with
Relapsed or Refractory Acute Myeloid Leukemia
A Phase I, Open-label, Adaptive Dose-escalation, Multicenter Study to Evaluate the Tolerability,
Safety, Pharmacokinetics, and Anti-tumor Activity of ADCT-402 in Patients with Relapsed or
Refractory B-Cell Lineage Acute Lymphoblastic Leukemia (B-ALL)
Claxton, David
PSHCI-16-002
An Open-label, Multi-center, Expanded Treatment Protocol of Midostaurin (PKC412) in Adult Patients
With Newly Diagnosed Fms-like Tyrosine Kinase Receptor (FLT3) Mutated Acute Myeloid Leukemia Christine Capper, 717-531(AML) Who Are Eligible for Standard Induction and Consolidation Chemotherapy
0003 ext 285453
Pu, Jeffrey
PSCI-16-005
A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 in Patients with Chronic
Lymphocytic Leukemia (CLL) who are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy
LEUKEMIA
4/25/2017
Page 5 of 12
COG Contact 717-531-6012
Brian Couch 717-531-0003
ext 285861 pager 0406
Christine Capper, 717-5310003 ext 285453
Brian Couch 717-531-0003
ext 285861 pager 0406
Kathryn Byrnes 717-5313098
Brian Couch 717-531-0003
ext 285861 pager 0406
Brian Couch 717-531-0003
ext 285861 pager 0406
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Claxton, David
PSCI-16-032
Pu, Jeffrey
PSCI-16-036
Pu, Jeffrey
PSCI-16-037
Claxton, David
Title
CRC
A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221
(CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid
Brian Couch 717-531-0003
Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (IDHENTIFY)
ext 285861 pager 0406
Brian Couch 717-531-0003
ext 285861 pager 0406
PSCI-16-038
A Multi-Center, Open-Label, Study to Evaluate the Safety and Efficacy of Ublituximab (TG-1101) in
Combination with TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With
TGR-1202 Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic
Lymphocytic Leukemia (CLL)
A Phase 2/3 Multicenter, Open-label, 3 arm, 2 stage Randomized Study of ASP2215 (Gilteritinib),
Combination of ASP2215 Plus Azacitidine, and Azacitidine Alone in the Treatment of Newly
Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction
Chemotherapy
Rybka, Witold
PSHCI-14-059
A Study to Evaluate Biomarkers of Sensitivity and Resistance in Patients with Relapsed/Refractory
Hodgkin Lymphoma Who Are Treated with Brentuximab Vedotin
Christine Capper, 717-5310003 ext 285453
Rizvi, Syed
PSHCI-14-113
Phase II Trial of Intravenous Fenretinide (N-(4-hydroxyphenyl) retinamide, 4-HPR) Emulsion for
Patients with Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL)
Brian Couch 717-531-0003
ext 285861 pager 0406
Rybka, Witold
PSHCI-16-027
Phase Ib Trial of Pembrolizumab(MK-3475)in Combination with Dinaciclib(MK-7965)in Subjects with
Hematologic Malignancies (KEYNOTE-155)
Brian Couch 717-531-0003
ext 285861 pager 0406
Brian Couch 717-531-0003
ext 285861 pager 0406
Christine Capper, 717-5310003 ext 285453
LYMPHOMA
4/25/2017
Page 6 of 12
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
MDS
(None as of 04/25/2017)
MELANOMA
4/25/2017
Neves, Rogerio
PSHCI-09-052
Drabick, Joseph
PSHCI-14-057
Drabick, Joseph
PSHCI-15-069
Drabick, Joseph
PSHCI-16-001
The Collection of Blood, Tissue and Phenotypic Data in Patients Diagnosed with Skin Cancers and
Subsequent Metastases for Inclusion in a Repository and Use in Outcome Studies
A Phase 1/2 Study of the Concomitant Administration of Indoximod plus Ipilimumab for Adult Patients
with Metastatic Melanoma
A Phase 1b, Open-label, Multicenter, Dose-escalation Trial of Intratumoral Injections of SD-101 in
Combination With Pembrolizumab in Patients With Metastatic Melanoma
A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in
Patients With High Risk Resected Melanoma
Mallett, Kimberly, A
PSCI-16-051
Efficacy of a Behavioral Intervention to Reduce Skin Cancer Risk Among Patients
Page 7 of 12
Rogerio Neves 717-5318371, [email protected]
Jennifer Hallman 717-5310003 ext 287412
Jennifer Hallman 717-5310003 ext 287412
Jennifer Hallman 717-5310003 ext 287412
Sarah Ackerman 814-8654222
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
MYELOFIBROSIS
MYELOMA
(None as of 04/25/2017)
Talamo, Giampaolo
PSHCI-11-118
CRC
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic Brian Couch 717-531-0003
High-Risk Smoldering Multiple Myeloma
ext 285861 pager 0406
Talamo, Giampaolo
PSHCI-13-052
Rybka, Witold
PSHCI-14-027
A Phase 2, Multicenter, Multi-Cohort, Open-Label Study of Pomalidomide in Combination with LowDose Dexamethasone or Pomalidomide in Combination with Low-Dose Dexamethasone and
Daratumumab in Subjects with Relapsed or Refractory Multiple Myeloma Following Lenalidomide
Based Therapy in the First or Second Line Setting (CC-4047-MM-014)(PSHCI 13-052)
Randomized Phase III Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) Versus
Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite Duration
Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma
(ENDURANCE)
Rybka, Witold
PSHCI-16-027
Phase Ib Trial of Pembrolizumab(MK-3475)in Combination with Dinaciclib(MK-7965)in Subjects with
Hematologic Malignancies (KEYNOTE-155)
Brian Couch 717-531-0003
ext 285861 pager 0406
Brian Couch 717-531-0003
ext 285861 pager 0406
Brian Couch 717-531-0003
ext 285861 pager 0406
PHASE I
A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with
Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b)
Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer (Helix BioPharma)
A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to
Programmed Death - 1 (PD 1), as Single Therapy and in Combination With Other Anti-Cancer
Therapies in Patients With Advanced Malignancies
A Phase I/II Study of Glembatumumab Vedotin in Patients with gpNMB-Expressing, Advanced or
Metastatic Squamous Cell Carcinoma of the Lung
A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And
Genitourinary Tumors
Rebecca Hale 717-5311003 pager 3656
Belani, Chandra
PSHCI-14-065
Yee, Nelson Shu-sang
PSHCI-15-053
Belani, Chandra
PSHCI-15-107
Yee, Nelson Shu-sang
PSHCI-15-110
Glantz, Michael
PSHCI-16-011
Yee, Nelson Shu-sang
PSCI -16-020
Lea May 717-531-0003 ext
285550 pager 3973
Rebecca Hale 717-5311003 pager 3656
Kathleen Rizzo 717-5310003 ext 289630
Cindy Campbell Baird 717Immunological targeting of CD-133 in recurrent glioblastoma: A multi-center Phase I translational and 531-5777
clinical study of an autologous CD-133 DC vaccine
[email protected]
A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety,
Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With
Lea May 717-531-0003 ext
Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
285550 pager 3973
Rybka, Witold
PSHCI-16-027
Phase Ib Trial of Pembrolizumab(MK-3475)in Combination with Dinaciclib(MK-7965)in Subjects with
Hematologic Malignancies (KEYNOTE-155)
Brian Couch 717-531-0003
ext 285861 pager 0406
COG Contact 717-531-6012
Rebecca Hale 717-5311003 pager 3657
PREVENTION (None as of 04/25/2017)
SARCOMA
4/25/2017
McGregor, Lisa
SOLID TUMOR
PSHCI-15-031
Randomized Phase III Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab
(AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly
Diagnosed Metastatic Ewing Sarcoma
Belani, Chandra
PSCI-15-094
Molecular Analysis for Therapy Choice (MATCH)
Page 8 of 12
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
SYMPTOM MANAGEMENT/SUPPORTIVE CARE (None as of 04/25/2017)
THORACIC
Wagner, Henry
PSHCI-09-078
Phase III Comparison of Thoracic Radiotherapy Regimens in patients with Limited Small Cell Lung
Cancer Receiving Cisplatin and Etoposide (RTOG 0538)
Rebecca Hale 717-5311003 pager 3656
Belani, Chandra
PSHCI-14-065
Belani, Chandra
PSHCI-14-067
Belani, Chandra
PSHCI-14-088
Belani, Chandra
PSHCI-14-093
A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with
Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b)
Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer (Helix BioPharma)
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer:
Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK)
Fusion Protein (An ALCHEMIST Treatment Trial) (E4512)
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
(A151216)
Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with
Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung
Cancer (NSCLC)
Belani, Chandra
PSCI-16-093
Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) A Randomized Phase III Study of Nivolumab Rebecca Hale 717-531after Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
1003 pager 3656
Belani, Chandra
PSHCI-14-055
Lung-MAP: Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Rebecca Hale 717-5311003 pager 3656
Squamous Cell Lung Cancer
Belani, Chandra
PSHCI-15-033
Belani, Chandra
PSCI-15-094
Belani, Chandra
PSHCI-15-107
Belani, Chandra
PSHCI-16-028
Higgins, William
NCI-VN-Bronch
Rebecca Hale 717-5311003 pager 3656
Rebecca Hale 717-5311003 pager 3656
Rebecca Hale 717-5311003 pager 3656
Rebecca Hale 717-5311003 pager 3656
THORACIC
4/25/2017
Phase 1/2, First-in-Human, Dose-Escalation Study of X-396 in Patients With Advanced Solid Tumors Rebecca Hale 717-531and Expansion Phase in Patients With ALK-positive Non-Small Cell Lung Cancer
1003 pager 3656
Rebecca Hale 717-531Molecular Analysis for Therapy Choice (MATCH)
1003 pager 3657
A Phase I/II Study of Glembatumumab Vedotin in Patients with gpNMB-Expressing, Advanced or
Rebecca Hale 717-531Metastatic Squamous Cell Carcinoma of the Lung
1003 pager 3656
Robin Walters 717-531-0003
Tissue and Blood Collection from Patients with Suspected Lung Cancer
ext 285229
William Higgins 814-865Piloting a Virtual Navigation (VN) System for Bronchoscopic Tissue Sampling
0186 ext 186
Page 9 of 12
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
PEDIATRIC TRIALS
BRAIN
McGregor, Lisa
COG-ACNS0332
McGregor, Lisa
COG-ACNS0831
Brown, Valerie
PSHCI-14-024
McGregor, Lisa
PSHCI-15-003
CORRELATIVE SCIENCE/BANKING
McGregor, Lisa
COG-ABTR01B1
McGregor, Lisa
COG-ACCRN07
A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens
including Rare Pediatric Tumors.
Protocol for the Enrollment on the Official COG Registry, the Childhood Cancer Research Network
(CCRN)
McGregor, Lisa
COG-ACNS02B3
A COG Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
COG Contact 717-531-6012
McGregor, Lisa
COG-AEWS07B1
A Children's Oncology Group Protocol for Collecting and Banking Ewing Sarcoma Specimens
COG Contact 717-531-6012
McGregor, Lisa
COG-ANHL04B1
Rare and Cutaneous Non-Hodgkin Lymphoma Registry
COG Contact 717-531-6012
McGregor, Lisa
COG-AOST06B1
A COG Protocol for Collecting and Banking Osteosarcoma Specimens
COG Contact 717-531-6012
McGregor, Lisa
COG-AREN03B2
Renal Tumor Classification, Biology, and Banking Study
COG Contact 717-531-6012
McGregor, Lisa
GI
COG-D9902
A COG Soft Tissue Sarcoma Biology and Banking Protocol
COG Contact 717-531-6012
Treatment of Children with All Stages of Hepatoblastoma
COG Contact 717-531-6012
McGregor, Lisa
COG-AHEP0731
GU
(None as of 04/25/2017)
HEAD AND NECK
(None as of 04/25/2017)
HEMATOLOGY/OTHER
Greiner, Robert, J
4/25/2017
Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a Pro-Apoptotic
Agent in Other than Average Risk Medulloblastoma/PNET Patients
COG Contact 717-531-6012
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed
Ependymoma Ages 1-21 years
COG Contact 717-531-6012
Kathryn Byrnes 717-531Molecular-Guided Therapy for the Treatment of Patients with Relapsed and Refractory Childhood
3098; Suzanne Treadway
Cancers (NMTRC)
717-531-3097
A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND#
61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 764038, IND# 4308) in Children with Refractory,
Relapsed or Progressive Neuroblastoma
COG Contact 717-531-6012
PSCI-16-078
COG Contact 717-531-6012
COG Contact 717-531-6012
A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best
Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
Undergoing Hematopoietic Stem Cell Transplant
COG Contact 717-531-6012
Page 10 of 12
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
LEUKEMIA
4/25/2017
McGregor, Lisa
COG-AALL05B1
McGregor, Lisa
COG-AALL08B1
McGregor, Lisa
COG-AALL0932
McGregor, Lisa
PSHCI-12-012
McGregor, Lisa
PSHCI-14-094
Brown, Valerie
PSHCI-15-064
Brown, Valerie
PSHCI-15-075
McGregor, Lisa
LYMPHOMA
PSCI-16-135
A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic
Leukemia Research Specimens
Classification of Newly Diagnosed Acute Lymphoblastic Leukemia
Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or
Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic
Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
(AALL1131)
A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented
BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and TLymphoblastic Lymphoma (T-LLy) (AALL1231)
COG Contact 717-531-6012
COG Contact 717-531-6012
COG Contact 717-531-6012
COG Contact 717-531-6012
COG Contact 717-531-6012
Kathryn Byrnes 717-531Phase I Study of Carfilzomib in Combination with Cyclophosphamide and Etoposide for Children with 3098; Suzanne Treadway
Relapsed and Refractory Solid Tumors and Leukemias
717-531-3097
A Phase 2, Multi-center, Single-arm, Open-label Study to Evaluate the Activity, Safety and
Pharmacokinetics of Lenalidomide (Revlimid®) in Pediatric Subjects 1 to ≤ 18 Years of Age with
Kathryn Byrnes 717-531Relapsed or Refractory Acute Myeloid Leukemia
3098
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or
Myelodysplastic Syndrome in Younger Patients With Down Syndrome
COG Contact 717-531-6012
McGregor, Lisa
PSHCI-15-010
McGregor, Lisa
MDS
PSHCI-15-084
A Phase III Randomized, Open Label, Multi-Center Study of the Safety and Efficacy of Apixaban for
Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction
Chemotherapy in Children with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma
(T or B cell) Treated with Pegylated Asparaginase
COG Contact 717-531-6012
A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed
High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents
COG Contact 717-531-6012
McGregor, Lisa
NEUROBLASTOMA
COG-AAML08B1
Biology Study of Transient Myeloproliferative Disorder (TMD) in Children with Down Syndrome (DS)
COG Contact 717-531-6012
McGregor, Lisa
COG-ANBL00B1
Neuroblastoma Biology Studies
Brown, Valerie
PSHCI-14-008
COG Contact 717-531-6012
Kathryn Byrnes 717-5313098; Suzanne Treadway
717-531-3097
McGregor, Lisa
PSHCI-14-085
Brown, Valerie
PSHCI-15-086
Brown, Valerie
PSHCI-16-023
A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma
(NMTRC)
Utilizing Response-and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk
Neuroblastoma (ANBL1232)
COG Contact 717-531-6012
Kathryn Byrnes 717-531A Pilot Study Using Molecular Guided Therapy with Induction Chemotherapy Followed by
3098; Suzanne Treadway
Maintenance with DFMO for Subjects with Newly Diagnosed High-Risk Neuroblastoma
717-531-3097
Kathryn Byrnes 717-5313098; Suzanne Treadway
NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)
717-531-3097
Page 11 of 12
OPEN CLINICAL TRIALS AT PENN STATE CANCER INSTITUTE
April 25, 2017
Adult Trials (pages 1-9) and Pediatric Trials (pages 10-12)
PI Name
Protocol No.
Title
CRC
OBSERVATIONAL
McGregor, Lisa
SARCOMA
PSHCI-15-111
McGregor, Lisa
PSHCI-12-077
Brown, Valerie
PSHCI-14-073
McGregor, Lisa
PSHCI-14-084
McGregor, Lisa
PSHCI-15-031
McGregor, Lisa
SOLID TUMOR
PSHCI-16-029
A Phase II Trial of Cyclophosphamide, Topotecan, and Bevacizumab (CTB) in Patients with
Relapsed/Refractory Ewing's Sarcoma and Neuroblastoma (POETIC)
A Phase II Study of Pazopanib (GW786034, NSC# 737754) in Children, Adolescents and Young
Adults with Refractory Solid Tumors
Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A
Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or
Minus Pazopanib (ARST1321)
Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab
(AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly
Diagnosed Metastatic Ewing Sarcoma
Phase II Study of Denosumab (NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory
Osteosarcoma
Brown, Valerie
PSHCI-15-051
An Early-Phase, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of Anti−PD-L1
Antibody (MPDL3280A) in Pediatric and Young Adult Patients with Previously Treated Solid Tumors
Brown, Valerie
PSHCI-15-064
Brown, Valerie
PSHCI-15-087
SYMPTOM MANAGEMENT/SUPPORTIVE CARE
4/25/2017
The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
COG Contact 717-531-6012
COG Contact 717-531-6012
COG Contact 717-531-6012
COG Contact 717-531-6012
COG Contact 717-531-6012
COG Contact 717-531-6012
Kathryn Byrnes 717-5313098; Suzanne Treadway
717-531-3097
Kathryn Byrnes 717-531Phase I Study of Carfilzomib in Combination with Cyclophosphamide and Etoposide for Children with 3098; Suzanne Treadway
Relapsed and Refractory Solid Tumors and Leukemias
717-531-3097
Kathryn Byrnes 717-531A Phase I/II, Multicenter, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of 3098; Suzanne Treadway
Cobimetinib in Pediatric and Young Adult Patients with Previously Treated Solid Tumors
717-531-3097
McGregor, Lisa
COG-ALTE05N1
Umbrella Long-term Follow-up Protocol
COG Contact 717-531-6012
McGregor, Lisa
COG-ALTE07C1
COG Contact 717-531-6012
Freiberg, Andrew
PSHCI-12-065
Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer
An open-label, cross-over, pharmacokinetic study to assess the safety and pharmacokinetics of
transdermal granisetron (Sancuso® patch) and IV granisetron in a pediatric oncology population
(ages 13-17) (Strakan Pharmaceuticals )
Page 12 of 12
Julie Vallati 717 531 3049