Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients

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.