Trial & Business Updates:

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Priority Lists

Activations

RTOG 0212Phase II-III Intergroup
A Phase II/III Randomized Trial of Two Doses (Phase III-Standard vs. High) and Two High Doe Schedules (Phase II-Once vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer
Study Coordinator(s)Zelanna Goldberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0339Phase II
"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

Closures

S0116Phase II

Permanent Closure Effective 2/15/04

A Phase II Trial of a D1/3-MAGE-3-His Fusion Protein (NSC-719274) with Adjuvant SB-AS02B (NSC-719275) for Patients with Selected Stage IV, M1a or M1b Metastatic Melanoma
Study Coordinator(s)Jeffrey S. Weber, M.D., Vernon K. Sondak, M.D., Mary L. Disis, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
Closure Date2004-02-15

Amendments, Revisions, Memoranda

E4697Phase III Intergroup

Amendment #2

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
N9841Phase III Intergroup

Memorandum

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0001Phase III

Revision #6

A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma
Study Coordinator(s)Deborah T. Blumenthal, M.D., Alexander M. Spence, M.D., Keith J. Stelzer, M.D.,Ph.D., Andrew Edward Sloan, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Radiation Oncologists
S0200Phase III

Revision #2

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0355Phase I

Revision #2

A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
Study Coordinator(s)Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S9925Ancillary

Amendment #6

Lung Cancer Specimen Repository Protocol, Ancillary
Action CodesFBR
Study Coordinator(s)Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, ECOG
SWOG-9512 (E1694)Phase III Intergroup

Memorandum

A Phase III Study of Adjuvant Ganglioside Vaccination GM2- KLM/QS-21 Therapy vs. High-Dose Interferon Alpha-2b (Intron A) for High Risk Melanoma (T4>4 mm Primary or Regional Lymph Node Metastasis)
Study Coordinator(s)Jeffrey A. Sosman, 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