Food and Drug Administration

Oncologic Drugs Advisory Committee

February 27, 2002


Trial Design Considerations and Appropriate Patient Populations for Studies of Investigational Agents for Adjuvant Therapy of Melanoma Given the Availability of an Approved Agent for this Indication

Issues in the Clinical Development of Investigational Agents Being Evaluated for the Post-surgical Adjuvant Treatment of High-Risk (Stage IIb and III) Melanoma   ppt   htm

Cure Rate Models and Adjuvant Trial Design for ECOG Melanoma Studies in the Past, Present, and Future, Joseph Ibrahim, PhD, Harvard School of Public Health, Dana-Farber Cancer Institute, and ECOG Statistical Center   ppt   htm

Melacine® Vaccine, Purpose: Discuss Proposed Second Pivotal Trial of Melacine Vaccine as Adjuvant Therapy for Intermediate Thickness Stage II Melanoma in Patients who Express HLA-A2 and/or HLA-C3, Corixa  ppt   htm

Efficacy and Safety of High-Dose IFN-alpha2b in Patients with High-Risk Resected Cutaneous Melanoma, John M. Kirkwood, MD, University of Pittsburgh Cancer Institute, ECOG Melanoma Committee   ppt   htm


Lynn E Spitler, MD, Northern California Melanoma Center  ppt   htm

Paul B Chapman MD, Clinical Immunology Service, Memorial-Sloan Kettering Cancer Center   ppt   htm

Clinical Trials in Patients with Resected Stage IIB and III Melanoma, Craig L Slingluff Jr, MD, University of Virginia, ECOG, ACOSOG   ppt   htm

Lynn M Schuchter, MD, University of Pennsylvania Cancer Center  ppt   htm