Trial & Business Updates:

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Priority Lists

Activations

S0410Phase II

Activation

Tandem Autologous Stem Cell Transplantation For Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
Study Coordinator(s)Eileen P. Smith, M.D., Patrick J. Stiff, M.D., Louis S. Constine, M.D., Thomas M. Grogan, M.D.
ParticipantsLimited Institutions: SWOG Approved Autologous BMT Facilities, Limited Institutions: BMT CTN Approved Autologous BMT Facilities

Closures

R9813Phase IIb

Temporary Closure

A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
Study Coordinator(s)Geoffrey R. Barger, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
Closure Date2006-11-01
S0117Phase II

Permanent Closure

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
Closure Date2005-10-15
S0415Phase II

Temporary Closure

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP
Closure Date2007-01-01
S0418Phase II

Temporary Closure

A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
Study Coordinator(s)Tomasz M. Beer, M.D., Christopher W. Ryan, M.D., Timothy W. Synold, Pharm. D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
Closure Date2006-05-01

Amendments, Revisions, Memoranda

C10001Phase II

Memorandum

A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571)(NSC # 716051,IND # 61135), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG
Study Coordinator(s)Margaret R. O'Donnell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
E4697Phase III Intergroup

Amendment #4

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
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0218Phase II

Memorandum

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
Study Coordinator(s)Linda L. Garland, M.D., Michael Lobell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0317Phase II

Memorandum

A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Study Coordinator(s)Michael S. Gordon, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG
S0330Phase II

Memorandum

U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
Study Coordinator(s)Karen H. Albritton, M.D., R. Lor Randall, M.D., Cheryl Coffin, M.D., Nancy Ratner, Ph.D., Scott Schuetze, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CTSU
S0341Phase II

Memorandum

Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Study Coordinator(s)Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0342Phase II

Memorandum

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0344Phase II

Revision #1

A Phase II Surgical Trial of Intralesional Resection of Low-Grade Intracompartmental Chondrosarcoma of Bone
Study Coordinator(s)R. Lor Randall, M.D., J. Sybil Biermann, M.D., Edward Y. Cheng, M.D., Julia Crim, M.D., Lester Layfield, M.D., Joseph Buckwalter, M.D., James Martin, M.D., George Demetri, M.D., Margaret von Mehren, M.D., Vivien Bramwell, M.D.,Ph.D.
ParticipantsIntergroup Coalition Against Sarcomas Members, Members, NCORP, Surgeons, ACOSOG
S0355Phase I

Amendment #5

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
S0414Phase II

Memorandum

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Study Coordinator(s)Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
S0415Phase II

Memorandum

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP

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