Adjuvant Interleukin2 (Proleukin)and 5-(3,3 Dimethyl-1-Triazeno) Imidazole-4-Carboxamide (DTIC) in Resected High-Risk Primary and Regionally Metastatic Melanoma

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.