Trial & Business Updates:

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Amendments, Revisions, Memoranda

C9710Phase III Intergroup

Memorandum

Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC #706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients with Untreated Acute Promyelocytic Leukemia
Action CodesER
Study Coordinator(s)Steven E. Coutre, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsPathologists, NCORP, Members

Revision #3

Phase III Randomized Trial of Fludarabine and Cyclophosphamide versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia.
Study Coordinator(s)Mohamad A. Hussein, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
E3695Phase III Intergroup

Memorandum

A Randomized Phase III Trial of Concurrent Biochemotherapy with Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon a-2b versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients with Metastatic Malignant Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsMedical Oncologists, NCORP, Members
E4494Phase III Intergroup

Memorandum

Phase III Trial of CHOP versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients with Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma
Study Coordinator(s)James K. Weick, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
E4697Phase III Intergroup

Amendment #3

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with "No Evidence of Disease" after Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Action CodesIP, AC, ER
Study Coordinator(s)Kim A. Margolin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
S0000Phase III

Amendment #2

Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Study Coordinator(s)Eric A. Klein, M.D., Ian M. Thompson Jr., M.D., Wael A. Sakr, M.D.
ParticipantsInstitutions listed in protocol Appendix 19.5
S0008Phase III Intergroup

Revision #13

Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D., John A. Thompson, M.D., Ralph J. Tuthill, M.D., John Vetto, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
S0108Phase II

Memorandum

Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D., William T. Bellamy, R. Ph.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0108Phase II

Memorandum

Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D., William T. Bellamy, R. Ph.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0109Phase II

Memorandum

A Phase II Study of Flavopiridol (NSC-649890) 1 Hour Bolus Days 1-3 Q 21 Days in Patients with Advanced Renal Cell Cancer
Study Coordinator(s)Peter J. Van Veldhuizen, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0117Phase II

Revision #3

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg™) and Standard Dose Ara-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Study Coordinator(s)John E. Godwin, M.D., Margaret R. O'Donnell, M.D., David R. Head, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0216Phase II

Revision #3

Docetaxel (NSC-628503), Cisplatin (NSC-119875), and 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed by Accerlerated Fractionation/Concomitant Boost Radiation and Concurrent Single Agent Cisplatin (NSC-119875), in Patients with Advanced Squamous Cell Head and Neck Cancer
Study Coordinator(s)David J. Adelstein, M.D., Ehab Hanna, M.D., P.G. Shankar Giri, M.D., S.G. Urba, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0327Phase II

Memorandum

A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer.
Study Coordinator(s)Primo N. Lara, Jr., M.D., Angela M. Davies, M.D., Paul H. Gumerlock, Ph.D., Wilbur A. Franklin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0339Phase II

Revision #1

"A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)."
Study Coordinator(s)Angela M. Davies, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9811Phase II

Revision #3

Phase II Study of Hydroxyurea for Unresectable Meningioma
Study Coordinator(s)Lode J. Swinnen, M.D., Geoffrey R. Barger, M.D., Elisabeth J. Rushing, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, ECOG
S9811Phase II

Revision #4

Phase II Study of Hydroxyurea for Unresectable Meningioma
Study Coordinator(s)Lode J. Swinnen, M.D., Geoffrey R. Barger, M.D., Elisabeth J. Rushing, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, ECOG
SWOG-8949Phase III

Memorandum

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
Study Coordinator(s)Robert C. Flanigan, M.D., Sydney E. Salmon, 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