Trial & Business Updates:

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Priority Lists

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Amendments, Revisions, Memoranda

C10403Phase II Intergroup

Memorandum - Case Report Forms

An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, Pathologists
S0931Phase III

Revision #4

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.
Action CodesIP, ER
Study Coordinator(s)Christopher W. Ryan, M.D., Elisabeth I. Heath, M.D., Primo N. Lara, Jr., M.D., Ganesh S. Palapattu, M.D., Philip C. Mack, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1001Phase II

Funding Memorandum

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Study Coordinator(s)Daniel O. Persky, M.D.
ParticipantsNCORP, Affiliates, CTSU, Members
S1007Phase III Intergroup

Funding Memorandum

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Action CodesNR
Study Coordinator(s)Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1007Phase III Intergroup

Memorandum - Forms Update

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Action CodesNR
Study Coordinator(s)Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1011Phase III Intergroup

Memorandum - Master Forms Set Update

A Phase III Surgical Trial to Evaluate The Benefit Of A Standard Versus An Extended Pelvic Lymphadenectomy Performed At Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer
Action CodesNR
Study Coordinator(s)Seth P. Lerner, M.D., Theresa M. Koppie, M.D., Ajjai S. Alva, M.D., Robert S. Svatek, M.D., Sumanta K. Pal, M.D., Francisco G. LaRosa, M.D., Rick Bangs
ParticipantsLimited: Credentialed Surgeons Listed on S1011 Abstract Page
S1115Phase II

Memorandum - AZD6244 Safety Report

Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
Action CodesER
Study Coordinator(s)Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1206 (8811)Phase II

Memorandum - ABT-888 Safety Report

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
Action CodesER
Study Coordinator(s)Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D.
ParticipantsSWOG
S1221Phase I-II

Revision #4

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1310Phase II

Funding Memorandum

Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
Study Coordinator(s)Richard D. Kim, M.D., Anthony El-Khoueiry, M.D.
ParticipantsMembers, NCORP, Affiliates
S1312Phase I

Memorandum - Inotuzumab Lot Extension

A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
Action CodesER, NR
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsLimited: Institutions Listed on the Title Page
S1312Phase I

Revision #4

A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
Action CodesER, NR
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsLimited: Institutions Listed on the Title Page
S1406Phase II

Funding Memorandum

Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Study Coordinator(s)E. Scott Kopetz, M.D., Heinz- Josef Lenz, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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