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