A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed melanoma metastatic to regional lymph
nodes with a clinically palpable mass Must have clinical evidence of the following:
Metastases in 1 nodal site All other nodes microscopically negative No intransit
metastases No extranodal extension OR Metastases in more than 1 nodal site More than 1
positive lymph node in a single site Intransit metastases Extranodal extension Must have
undergone complete resection of tumor, measuring at least 2 cm in diameter, within the
past 6 weeks No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life
expectancy: At least 6 months Hematopoietic: Hematocrit at least 30% WBC at least
3,000/mm3 Hepatic: Hepatitis B and C negative Renal: Not specified Other: Not pregnant or
nursing No active serious infection No active autoimmune disease HIV negative No other
malignancy within the last 5 years except squamous cell carcinoma of the skin, carcinoma
in situ of the cervix, superficial bladder carcinoma, early stage prostate cancer, or
noninvasive melanoma No active severe depression or psychiatric disorder with psychotic
symptoms No uncontrolled thyroid abnormalities

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since prior cytotoxic drugs (except for isolated limb perfusion) Endocrine therapy: No
concurrent systemic corticosteroids Radiotherapy: At least 6 months since prior
radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior
investigational drugs