Clinical Research Directory

Inclusion Criteria: * Patients must fulfill one of the following criteria: * T4 NO MO - Deep primary melanoma (\> 4.0 mm) with or without lymphadenectomy. * T1-4 N1-3 MO - Primary melanoma with regional lymph node metastases found at lymphadenectomy or sentinel lymph node sampling, but clinically undetectable (occult). * T1-4 N1-3 MO - Primary melanoma with clinically apparent (overt) regional lymph node metastases confirmed by lymphadenectomy. * T1-4 N1-3 MO - Recurrence of melanoma at the proximal regional lymph node(s). * Patients must have undergone a wide excision of the primary and, if \>1mm in depth, have completed sentinel lymph node sampling or lymphadenectomy as is standard of practice. Patients must have confirmation of adequate surgical margins around the primary lesion (1 or 2 cm minimum, for primary lesions of 1-2 mm depth; 2 cm for primary lesions equal to or greater than 2 mm depth). When entering this study with recurrent regional lymph node disease, the patient must be enrolled no later than 90 days from the date of lymphadenectomy. * For subungual melanomas a distal interphalangeal. amputation is required. For patients with regional lymph node recurrence, the same evidence for adequate margins around the primary are required as for patients at initial presentation. * For safety reasons, patients must be of age between 18 and 85. * Patients must have ECOG performance status 0-2. * Patients must have WBC \>3,000, platelet count \>100,000, and hematocrit \>33. * Patients must have SGOT and bilirubin \<2x normal; creatinine \<2.3; BUN \<33. * Patients must have no active medical or psychiatric disorders requiring therapy that would prevent completion of the protocol. * Patients must give written informed consent. Exclusion Criteria: * Patients for whom histopathologic examination of the primary or metastatic melanoma is not positive are ineligible. * Patients who have clinical, radiological, laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease are ineligible. * Patients with an active second cancer (except in situ cervical cancer, or basal or squamous skin cancer) are ineligible. Exceptions may be discussed with the principal investigator. * Patients with organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol, are ineligible. * Patients who have had prior adjuvant chemotherapy, immunotherapy, including preoperative infusion or perfusion therapy are ineligible. * Patients with recurrent melanoma at regional lymph nodes must not have been previously entered into this study. * Patients with more than one lymph node group involved are ineligible. * Women of child bearing age who are not on adequate birth control are ineligible. * Women who are pregnant or breast feeding are ineligible.