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Priority Lists

Activations

S0116Phase II

Activation

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
S0215Phase II Pilot
Docetaxel and Vinorelbine Plus Filgrastim with Weekly Trastuzumab for HER-2 Positive, Stage IV Breast Cancer, Phase II Pilot
Study Coordinator(s)Joseph J. Kash, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists

Closures

S0026Phase II

Temporary Closure Effective 9/10/02

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
Closure Date2003-05-01

Amendments, Revisions, Memoranda

C9710Phase III Intergroup

Amendment #4

Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC #706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients with Untreated Acute Promyelocytic Leukemia
Action CodesER
Study Coordinator(s)Steven E. Coutre, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsPathologists, NCORP, Members
E1199Phase III Intergroup

Amendment #3

A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paciltaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary Node-Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, Surgeons
N9841Phase III Intergroup

Revision #7

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0020Phase II

Amendment #1

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
S0033Phase III Intergroup

Revision #6

"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
S0108Phase II

Amendment #3

Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D., William T. Bellamy, R. Ph.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0120Biologic

Revision #1

A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasma Proliferative Disorders
Study Coordinator(s)Madhav V. Dhodapkar, M.D., Bart Barlogie, M.D.,Ph.D., John D. Shaughnessy, Jr., Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0204Phase II

Revision #1

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
S9908Phase III

Amendment #1

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
S9908Phase III

Revision #2

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

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