Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

71th Meeting
Holiday Inn
8120 Wisconsin Avenue
Bethesda, Maryland

Tentative Agenda                       February 27, 2002

 8:00   Call to Order and Opening Remarks           Stacy Nerenstone, M.D.
                                                               Chair, ODAC

         Introduction of Committee

         Conflict of Interest Statement                  Karen M. Templeton-Somers, Ph.D.
                                                               Executive Secretary, ODAC

Open Public Hearing

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

9:00    Efficacy and Safety of Adjuvant High-dose Interferon for High-risk Melanoma: ECOG and Intergroup Trial
                  John M. Kirkwood, MD - University of Pittsburgh Cancer Institute

Cure Rate Models and Adjuvant Trial Design for ECOG Studies in the Past, Present and Future
           Joseph G. Ibrahim, PhD - Harvard School of Public Health

9:45 FDA presentation

10:15  Break 

10:30  Committee Discussion

12:00   Lunch 

1:00    Open Public Hearing

Appropriate Study Design and Control for the Proposed Phase 3 Trial of
Investigational New Drug (IND) 2885, Melacine® (melanoma vaccine),
Corixa Corporation, for adjuvant treatment of melanoma

1:15 Sponsor Presentation                                Corixa Corporation

         Melacine® vaccine as adjuvant therapy for Stage II melanoma:                Martin A. Cheever, M.D.
         Issues for further development and regulatory approval                        Vice President, Medical Affairs

2:15    Committee Discussion

5:00    Adjourn