POLYVALENT VACCINE--PHASE III TRIAL IN STAGE IV MELANOMA

描述（申请人描述）：提议的目的

DESCRIPTION (Applicant's Description): The objective of the proposed project is to demonstrate the efficacy of a living irradiated polyvalent melanoma cell vaccine (PMCV) in a Phase III multicenter clinical trial examining AJCC Stage IV melanoma patients rendered clinically free of disease by surgery. This project's specific aims are: 1. Conduct a multicenter randomized double-blind Phase III trial of PMCV plus BCG versus placebo plus BCG as adjuvant immunotherapy in AJCC Stage IV melanoma patients rendered clinically free of disease (no evidence of disease (NED)) by surgical resection. 2. Determine the clinical results in a multicenter trial of surgical resection of distant metastases in Stage IV melanoma. 3. Determine whether new immunological and molecular markers can be used to detect subclinical metastatic melanoma and evaluate the response to adjuvant therapy. We hypothesize that these new techniques can be used as prognostic factors in predicting the outcome of adjuvant therapy for melanoma patients following surgery. Methodology to accurately identify patients with subclinical tumor burden would be very useful as stratification factors in clinical trials of adjuvant therapy, as well as in the management of the individual melanoma patient. 4. Develop methods to evaluate immunogenicity and monitor responses to PMCV by detecting antibody responses to active immunotherapy against specific melanoma-associated antigens and the induction of skin test responses to PMCV. Determine whether there is any correlation between such responses and the clinical course of vaccine patients in a prospective multicenter trial.