Trial & Business Updates:

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Priority Lists

Activations

CTSU/E1697Phase III Intergroup

Activation

Phase III Randomized Study of Four Weeks of High Dose IFN-alpha2b in Stage T2b N0, T3a-b N0, T4a-b N0, and T1-4, N1a, 2a, 3(Microscopic) Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsCTSU

Activation 10/15/02

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
S0107Phase II

Reactivation

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

Closures

S0031Phase II

Permanent Closure

Evaluation of ZD 1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
Study Coordinator(s)Daniel P. Petrylak, M.D., Peter J. Van Veldhuizen, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
Closure Date2002-10-15

Amendments, Revisions, Memoranda

C90003Phase II

Revision #1

Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
Study Coordinator(s)Kim A. Margolin, M.D.
ParticipantsLimited Institutions: BMT Members
JPR7Phase III Intergroup

Amendment #4

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
S0026Phase II

Revision #3

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
S0101Phase II

Revision #4

A Phase II Study of Gemcitabine Plus Irinotecan (CPT-11) In Patients With Esophageal Cancer.
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0116Phase II

Revision #1

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
S0119Phase II

Revision #1

Phase II Trial of Gemcitabine and Irinotecan in Patients with Untreated Extensive Stage Small Cell Lung Cancer (SCLC)
Study Coordinator(s)Wallace L. Akerley, M.D., Paul J. Hesketh, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0204Phase II

Amendment #2

A Phase II Trial of Thalidomide/Dexamethasone Induction Followed by Tandem Melphalan Transplant and Prednisone/Thalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients, (A BMT Study)
Study Coordinator(s)Mohamad A. Hussein, M.D., John D. Shaughnessy, Jr., Ph.D., James A. Waldron, M.D.,Ph.D., Jeffrey A. Zonder, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Limited Institutions: BMT Members
S9701Phase III

Revision #13

Phase III Randomized Trial of 12 Months VS 3 Months of Paclitaxel in Patients with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy (Intergroup)
Study Coordinator(s)Maurie Markman, M.D., Bradley J. Monk, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Pathologists, Surgeons, GOG, NCORP
S9806Phase II

Revision #4

Randomized Phase II Trial of Carboplatin/Gemcitabine Followed by Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer
Study Coordinator(s)Martin J. Edelman, M.D., Joseph I. Clark, M.D., David R. Gandara, M.D.
S9910Ancillary

Revision #5

Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary
Study Coordinator(s)Cheryl L. Willman, M.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, Affiliates
S9912Phase II

Revision #9

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study Coordinator(s)Harriet O. Smith, M.D., Amy D. Tiersten, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Surgeons, Pathologists, NCORP
S9916Phase III Intergroup

Revision #12

Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III.
Study Coordinator(s)Daniel P. Petrylak, M.D., Jeffrey A. Jones, M.D., Maha H.A. Hussain, M.D., Donna L. Berry, R.N.,Ph.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, CALGB, NCCTG, EPP, NCORP, Members, CTSU

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