Trial & Business Updates:

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Priority Lists

Activations

S0026Phase II
Evaluation of Interferon Alpha-2b and Thalidomide in Patients with Disseminated Malignant Melanoma, Phase II
Study Coordinator(s)Laura F. Hutchins, M.D., Joseph I. Clark, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9908Phase III

Activation

A Double-Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of L-Glutamine (in AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis in Head and Neck Cancer Patients, Phase III
Study Coordinator(s)V. Suzanne Klimberg, M.D., Omer Kucuk, M.D., Ehab Hanna, M.D., P.G. Shankar Giri, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists

Closures

S0109Phase II

Temporary Closure

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
Closure Date2002-02-01

Amendments, Revisions, Memoranda

JPR7Phase III Intergroup

Amendment #3

Intergroup (NCIC, SWOG) Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients with Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
Study Coordinator(s)Celestia S. Higano, M.D.
ParticipantsUCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, NCORP, Members
S0016Phase III

Amendment #1

A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Study Coordinator(s)Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU
S0020Phase II

Revision #2

A PHASE II STUDY OF ANTI-THYMOCYTE GLOBULIN AND CYCLOSPORINE FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
Study Coordinator(s)Charles Schiffer, M.D., Jeanne E. Anderson, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0107Phase II

Revision #2

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
S9927Phase III Intergroup

Revision #5

Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes, Phase III
Study Coordinator(s)Lori J. Pierce, M.D.
ParticipantsMedical Oncologists, Radiation Oncologists, Surgeons, NCCTG, RTOG, ACOSOG, ECOG, CALGB, NCORP, Members, NCIC-CTG, NSABP

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