A Randomized Phase III Trial of Concurrent Biochemotherapy with Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon a-2b versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients with Metastatic Malignant Melanoma

Pts. must have histologically confirmed, surgically incurable metastatic malignant melanoma; patients with ocular melanoma are not eligible; must have measurable disease; no evidence of cardiac problems (as outlined in the protocol); no evidence of symptomatic pulmonary disease (as outlined in the protocol); pts. must not have rec'd prior chemo or IL-2 or any prior systemic therapy for metastatic disease; prior immunotherapy, including IFN-a and vaccine therapy in the adjuvant setting is permitted, but must have been completed > 4 wks. prior to randomization; pts. must not have had any prior RT to areas of measurable disease unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior RT; no active brain mets or leptomeningeal disease allowed; pts. with history of brain mets must be 3 mths. from definitive therapy and have no evidence of active disease or edema on brain CT/MRI; pts. known to be HIV+ are ineligible; no organ allografts allowed; no corticosteriods; no significant medical disease other than malignancy (e.g., COPD, chronic infections, pts. with ascites or symptomatic pleural effusions); no seizure disorders.