PHASE III STUDY OF ADJUVANT GANGLIOSIDE VACCINATION VS INTERFERON THERAPY

$3,034M01FY2000RRNIH

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

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Abstract

The primary goal of this study is a comparison of treatment with an immunizing ganglioside preparation (GMK) as compared to high dose interferon (IFN Alfa 2b) in high risk melanoma patients. The design of this study is aimed at establishing equivalence between the two treatments. It is anticipated that 60 patients will enter this study at the UPCI. Approximately 400 patients will enter this study nationwide. The primary endpoints are relapse free and overall survival. A secondary endpoint is the correlation of pre-existing and vaccine induced IgM and IgG.

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