Trial & Business Updates:

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Priority Lists

Activations

AEWS0031Phase III Intergroup
Trial of Chemotherapy Intensification Through Interval Compression in Ewing Sarcoma and Related Tumors, Phase III
Study Coordinator(s)Karen H. Albritton, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Radiation Oncologists
S0202Phase II

Activation Revision

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Study Coordinator(s)Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0222Phase II
A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Coordinator(s)Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D., Zelanna Goldberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0327Phase II
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

Closures

C80002Phase II

Permanent Closure

A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers
Study Coordinator(s)Morton S. Kahlenberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
Closure Date2003-08-29
SWOG-9442Phase III Intergroup

PERMANENT CLOSURE EFFECTIVE 9/8/03

Randomized Multi-Institutional Phase III Trial of BEP and High Dose Chemotherapy Versus BEP Alone in Previously Untreated Patients With Poor and Intermediate Risk Germ Cell Tumors
Study Coordinator(s)Kim A. Margolin, M.D., Patrick J. Stiff, M.D., Michael F. Sarosdy, M.D.
ParticipantsLimited Institutions: SWOG Approved Autologous BMT Facilities
Closure Date2003-09-08

Amendments, Revisions, Memoranda

Revision #2

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
E4697Phase III Intergroup

Memorandum

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
N9741Phase III Intergroup

Memorandum

A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, Surgeons, NCORP
S0107Phase II

Memorandum

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP
S0116Phase II

Revision #6

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
S0117Phase II

Revision #1

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
S9704Phase III Intergroup
A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas(with Possible Late Autologous Stem Cell Transplant) for Patients with Diffuse Aggressive Non-Hodgkin’s Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups (A BMT Study)
Study Coordinator(s)Patrick J. Stiff, M.D., Avayporn P. Nademanee, M.D., Richard I. Fisher, M.D., Louis S. Constine, M.D., Raymond R. Tubbs, D.O., James Cook, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, ECOG, NCIC-CTG
S9921Phase III Intergroup

Revision #15

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
Study Coordinator(s)L. Michael Glode, M.D., Maha H.A. Hussain, M.D., Gregory P. Swanson, M.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists, EPP, CALGB, CTSU Institutions in the United States
S9922Phase III

Revision #7

A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients with Refractory Multiple Myeloma
Study Coordinator(s)Mohamad A. Hussein, M.D., James K. Weick, M.D.
ParticipantsNCORP, Members
S9925Ancillary

Amendment #5

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

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