Trial & Business Updates:

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Priority Lists

Activations

S0031Phase II

Activation

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
S9915Phase II

Activation Notice

A Phase II Study of PN401, 5-FU, and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach.
Study Coordinator(s)James H. Doroshow, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP

Closures

Amendments, Revisions, Memoranda

S0004Phase I

Revision #1

A Phase I Study of Tirapazamine/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., Janice Ryu, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0008Phase III Intergroup

Revision #5

Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D., John A. Thompson, M.D., Ralph J. Tuthill, M.D., John Vetto, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
S0014Phase II

Revision #2

Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High Risk Localized Aggressive Histologies of Non-Hodgkin’s Lymphoma, Phase II
Study Coordinator(s)Thomas P. Miller, M.D., B. Dino Stea, M.D.,Ph.D., Catherine P. Leith, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
S0019Phase III

Revision #1

A Randomized Phase III Trial of ICE Chemotherapy With or Without Rituximab for the Treatment of Relapsed or Refractory CD20 Expressing Agressive B-Cell Non-Hodgkin's Lymphomas in Patients Not Suitable for High Dose Therapy and PBSCT.
Study Coordinator(s)David G. Maloney, M.D.,Ph.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S9630Phase III Intergroup

Revision #6

A Randomized Comparison of Medroxyprogesterone Acetate (MPA) and Observation For Prevention of Endometrial Pathology in Postmenopausal Breast Cancer Patients Treated with Tamoxifen
Study Coordinator(s)Ronald K. Potkul, M.D., Caryl G. Salomon, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CALGB, NCORP
S9704Phase III Intergroup

Revision #9

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
S9901Phase III Intergroup

Revision #4

A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients with Advanced Stage Poor Prognosis Hodgkin’s Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin’s Disease, Intergroup
Study Coordinator(s)Ellen R. Gaynor, M.D., Stephen J. Forman, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, ECOG, CALGB, NCORP
SWOG-9431Ancillary

Revision #8

Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary
Study Coordinator(s)Jeffrey A. Sosman, M.D., Vernon K. Sondak, M.D., Ralph J. Tuthill, M.D., Cecilia M. Fenoglio-Preiser, M.D., Marilyn L. Slovak, Ph.D., Robert P. Whitehead, M.D., Diane L. Persons, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, 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