Trial & Business Updates:

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Priority Lists

Activations

CTSU/E1412Phase II Intergroup

Activation- Open to Accrual Effective 6/1/2014

Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs. RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
Action CodesFBR
Study Coordinator(s)Jennifer Amengual, M.D.
ParticipantsCTSU
S1206 (8811)Phase II

Re-Activation Effective 6/1/14

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
Action CodesER, NR
Study Coordinator(s)Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D.
ParticipantsSWOG
S1400Phase II-III Intergroup

Memorandum - IRB Distribution

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Study Coordinator(s)Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1400DPhase II Intergroup
A BIOMARKER DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER A PHASE II STUDY OF AZD4547 FOR PREVIOUSLY TREATED FGFR-POSITIVE PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER
Study Coordinator(s)Charu Aggarwal, M.D., MPH, Primo N. Lara, Jr., M.D., Vassiliki A. Papadimitrakopoulou, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1400EPhase II-III Intergroup
Phase II/III Randomized Study of Rilotumumab plus Erlotinib versus Erlotinib as Second Line Therapy For Biomarker Selected Patients With Squamous Cell Lung Cancer
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU

Closures

S1107Phase II

Permanent closure - effective 5/29/14

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
Action CodesER, NR
Study Coordinator(s)Przemyslaw W. Twardowski, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU
Closure Date2014-05-29

Amendments, Revisions, Memoranda

S0518Phase III

Memorandum - Investigator and Patient Letters

Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Action CodesIP, ER
Study Coordinator(s)James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0635Phase II

Memorandum - OSI-774 Safety Report

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
Action CodesER
Study Coordinator(s)Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0709Phase II

Funding Memorandum

A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS-2) Selected by Serum Proteomics
Study Coordinator(s)Primo N. Lara, Jr., M.D., Paul J. Hesketh, M.D., Philip C. Mack, Ph.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Affiliates
S0711Phase I

Funding Memorandum

Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517; IND-73969) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction."
Action CodesNR
Study Coordinator(s)John Sarantopolous, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0777Phase III Intergroup

Revision #19

A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
Action CodesER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0800Phase II

Memorandum - Study Co-Chair

A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
Action CodesNR
Study Coordinator(s)Zeina Nahleh, M.D., Daniel F. Hayes, M.D., Anne F. Schott, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, US INSTITUTIONS ONLY
S0819Phase III Intergroup

Funding Memorandum

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Action CodesER, NR
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D., David R. Gandara, M.D., Thomas J. Semrad, M.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, CTSU Institutions in the United States
S0819Phase III Intergroup

Temporary Closure - Effective 6/1/2014

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Action CodesER, NR
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D., David R. Gandara, M.D., Thomas J. Semrad, M.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, CTSU Institutions in the United States
S0905Phase II

Funding Memorandum

A Phase I / Randomized Phase II Study of Cediranib (NSC #732208) Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma
Action CodesNR
Study Coordinator(s)Anne Tsao, M.D., Nicholas J. Vogelzang, M.D., Ignacio I. Wistuba, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0919Phase II

Funding Memorandum

A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Edward Copelan, MD, Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0931Phase III

Funding Memorandum

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.
Action CodesNR
Study Coordinator(s)Christopher W. Ryan, M.D., Elisabeth I. Heath, M.D., Primo N. Lara, Jr., M.D., Ganesh S. Palapattu, M.D., Philip C. Mack, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1001Phase II

Funding Memorandum

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Action CodesNR
Study Coordinator(s)Daniel O. Persky, M.D.
ParticipantsNCORP, Affiliates, CTSU, Members
S1001Phase II

Memorandum - Prestudy Form

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Action CodesNR
Study Coordinator(s)Daniel O. Persky, M.D.
ParticipantsNCORP, Affiliates, CTSU, Members
S1007Phase III Intergroup

Memorandum - Prestudy Form

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Action CodesNR
Study Coordinator(s)Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1011Phase III Intergroup

Funding Memorandum

A Phase III Surgical Trial to Evaluate The Benefit Of A Standard Versus An Extended Pelvic Lymphadenectomy Performed At Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer
Study Coordinator(s)Seth P. Lerner, M.D., Theresa M. Koppie, M.D., Ajjai S. Alva, M.D., Robert S. Svatek, M.D., Sumanta K. Pal, M.D., Francisco G. LaRosa, M.D., Rick Bangs
ParticipantsLimited: Credentialed Surgeons Listed on S1011 Abstract Page
S1014Phase II

Memorandum - Abiraterone Acetate Safety Reports

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesER
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1014Phase II

Memorandum - Abiraterone Acetate Safety Reports

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesER
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1014Phase II

Revision #3

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesER
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1107Phase II

Funding Memorandum

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
Action CodesER, NR
Study Coordinator(s)Przemyslaw W. Twardowski, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU
S1107Phase II

Memorandum - OSI-774 Safety Report

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
Action CodesER, NR
Study Coordinator(s)Przemyslaw W. Twardowski, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU
S1115Phase II

Funding Memorandum

Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
Action CodesNR
Study Coordinator(s)Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1117Phase II Intergroup

Funding Memorandum

A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Action CodesNR
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, CTSU
S1201Phase II Pilot

Funding Memorandum

A Randomized Phase II Pilot Study Prospectively Evaulating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer
Action CodesNR
Study Coordinator(s)Syma Iqbal, M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1203Phase III

Funding Memorandum

A Randomized Phase III Study of Standard Cytarabine Plus Daunomycin (7+3) Therapy versus Idarubicin with High Dose Cytarabine (IA) with or without Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
Action CodesNR
Study Coordinator(s)Guillermo Garcia-Manero, M.D., Jerald P. Radich, M.D., Min Fang, M.D.,Ph.D., John Pagel, MD, PhD
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1206 (8811)Phase II

Funding Memorandum

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
Action CodesER, NR
Study Coordinator(s)Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D.
ParticipantsSWOG
S1207Phase III

Funding Memorandum

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. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Action CodesAC, ER
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1207Phase III

Memorandum - Adverse Event Management

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. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Action CodesAC, ER
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1207Phase III

Revision #2

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. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Action CodesAC, ER
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1211Phase I-II

Funding Memorandum

A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Action CodesNR
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists
S1216Phase III

Funding Memorandum

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
Action CodesNR
Study Coordinator(s)Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY
S1221Phase I-II

Funding Memorandum

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER, NR
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1221Phase I-II

Memorandum - Dabrafenib Safety Reports

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER, NR
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1221Phase I-II

Revision #3

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER, NR
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1222Phase III

Memorandum - Temperature Excursion Monitors and AG Mednet Training Slides

Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial In Postmenopausal Patients With Hormone-Receptor Positive Stage IV Breast Cancer.
Action CodesNR
Study Coordinator(s)George Somlo, M.D., Halle C.F. Moore, M.D., Daniel F. Hayes, M.D.
ParticipantsNCORP, Affiliates, Members, Medical Oncologists, Surgeons
S1304Phase II Intergroup

Funding Memorandum

A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1310Phase II

Memorandum - Trametinib Safety Report

Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
Action CodesER
Study Coordinator(s)Richard D. Kim, M.D., Anthony El-Khoueiry, M.D.
ParticipantsMembers, NCORP, Affiliates
S1312Phase I

Memorandum - Master Forms Set Update

A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
Action CodesER
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsLimited: Institutions Listed on the Title Page
S1313Phase I-II

Funding Memorandum

A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma
Action CodesER, NR
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1313Phase I-II

Memorandum - PEGPH20 Safety Report

A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma
Action CodesER, NR
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
SWOG-8375Phase II

Memorandum - IND Withdrawal

The Treatment of Favorable Histology Non-Hodgkin's Lymphoma with High Dose Pulse Chlorambucil and Recumbinant DNA Alpha-2 Interferon TEMPORARILY CLOSED: 7/26/85
Action CodesER
Study Coordinator(s)V. Ratanatharathorn, M.D., S.E. Jones, M.D.
SWOG-8624Phase III

Memorandum - IND Withdrawal

A Phase III Randomized Trial of Combination Therapy for Multiple Myeloma; Comparison of (1) VMCP/VBAP to VAD or VMCPP/VBAPP for Induction; (2) Alpha-2b Interferon or No Therapy for Maintenance; and 3) Alpha-2b Interferon + Dexamethasone for Incomplete or Non-Responders; and (4) VAD Plus Verapamil For Incomplete or Non-Responders on VAD
Action CodesER
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D., Sheikh Saeed, M.D.
SWOG-8809Phase III

Memorandum - IND Withdrawal

A Phase III Study of Alpha-Interferon Consolidation Following Intensive Chemotherapy with ProMACE- MOPP (Day 1-8) in Patients with Low Grade Malignant Lymphomas
Action CodesER
Study Coordinator(s)Bruce W. Dana, M.D., Carl Kjeldsberg, M.D., Richard I. Fisher, M.D.
SWOG-8809Phase III

Memorandum - IND Withdrawal

A Phase III Study of Alpha-Interferon Consolidation Following Intensive Chemotherapy with ProMACE- MOPP (Day 1-8) in Patients with Low Grade Malignant Lymphomas
Action CodesER
Study Coordinator(s)Bruce W. Dana, M.D., Carl Kjeldsberg, M.D., Richard I. Fisher, M.D.
SWOG-8949Phase III

Memorandum - IND Withdrawal

A Randomized Comparison of Nephrectomy Followed by Interferon Alpha 2-b (Intron-A) vs. Interferon Alpha 2-b (Intron-A) Alone in Patients with Advanced Renal Cell Carcinoma
Action CodesER
Study Coordinator(s)Robert C. Flanigan, M.D., Sydney E. Salmon, M.D.
SWOG-8993Phase II

Memorandum - IND Withdrawal

Phase II Study of High Dose Melphalan with Hemopoietic Stem Cell Support and GM-CSF in Refractory Multiple Myeloma (MM)
Action CodesER
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D.
SWOG-8993Phase II

Memorandum - IND Withdrawal

Phase II Study of High Dose Melphalan with Hemopoietic Stem Cell Support and GM-CSF in Refractory Multiple Myeloma (MM)
Action CodesER
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D.
SWOG-9028Phase III

Memorandum - IND Withdrawal

A Phase III Randomized Trial of Combination Therapy for Multiple Myeloma Comparison of (1) VAD to VAD/ Quinine for Induction with Crossover to VAD/ Quinine for VAD Induction Failures; (2) Alpha-2b Interferon or Alpha-2b Interferon plus Prednisone for Remission Maintenance
Action CodesER
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D., Thomas M. Grogan, M.D.
SWOG-9122Phase II

Memorandum - IND Withdrawal

Evaluation of 5-Fluorouracil By Intermittent Infusion in Combination with Alpha-Interferon for Patients with Advanced Renal Cell Carcinoma, Phase II
Action CodesER
Study Coordinator(s)Laurence Elias, M.D., Julie A. Kish, M.D.
SWOG-9350Phase II Pilot

Memorandum - IND Withdrawal

Limited Institution Pilot Trial of Alpha Interferon with Combination Chemotherapy in Disseminated Malignant Melanoma, Phase II
Action CodesER
Study Coordinator(s)Kim A. Margolin, M.D., Lawrence E. Flaherty, M.D.

Other New Items

  • IP - Pts Must Be Informed
  • AC - Consent Must Be Amended
  • CBR - No Registration Allowed until IRB Review
  • RC - Formal Re-consent Required
  • FBR - Full Board Review Required
  • ER - Expedited Review Acceptable
  • NR - No IRB Review Required