Food and Drug Administration
Oncologic Drugs Advisory Committee
February 27, 2002
Slides
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
OPEN PUBLIC HEARING
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