A Phase II Trial of a D1/3-MAGE-3-His Fusion Protein (NSC-719274) with Adjuvant SB-AS02B (NSC-719275) for Patients with Selected Stage IV, M1a or M1b Metastatic Melanoma

Pts. MUST have frozen tumor specimens submitted to GSK Biologicals in Belgium for MAGE-3 testing prior to Screening Registration - results must be positive in order for pt. to be eligible for Treatment Registration; pts. must have histologically-documented Stage IV, M1a or M1b metastatic melanoma considered incurable by surgery, RT or limb perfusion; pts. must have measurable disease outside any area of prior limb perfusion; PS 0-1; at least 28 days from prior RT, chemotherapy, biologic therapy, adjuvant therapy or surgery; at least 3 weeks from prior limb perfusion and recovered from all toxicities; pts. must agree to have specimens submitted for testing as outlined in Section 15.1; institutions must offer pts. the opportunity to participate in specimen banking; pts. w/metastatic mucosal melanoma are eligible; pts. must not have prior malignancy except: adequately treated basal cell or squamous cell skin ca, in situ cervical ca, adequately treated Stage I or II ca from which pt. is currently disease-free, or any other ca from which the pt. has been disease-free for at least 5 yrs; pts. must not have uveal or choroidal primary melanoma; pts. must not have had prior chemotherapy, biologic or other treatment for Stage IV disease or prior MAGE-3 peptide or protein vaccine preparation; pts. must not have AIDS, HIV-1 or HIV, Hepatitis B or C; pts. must not have ONLY non-measurable disease; pts. must not be pregnant or nursing or not agreeable to use an effective contraceptive method; pts. must not have a history of brain mets; M1c patients are ineligible.