PHASE II TRIAL OF GM2 KHL/QS21 VACCINE WITH INTERFERON ALPHA 2B IN MELANOMA

$0M01FY2001RRNIH

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

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Abstract

The main objectives of this Phase II study are to determine whether the anti-GM2 antibody response induced by GM2-KLH + QS-21 vaccine in patients with resected melanoma is diminished when high-dose interferon alfa-2b is administered during or following initiation of vaccination and to assess the toxicities of GM2-KLH + QS-21 when administered with high-dose interferon alfa-2b. The primary endpoint is the induction of the IgM & IgG antibodies against GM2 after vaccinations measured within two weeks of the fifth immunization.

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