A Phase I/II Trial of a Human Anti-Idiotypic Monoclonal Antibody Vaccine (4B5) Which Mimics the GD2 Antigen, in Patients With Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Pathologically proven stage III or IV melanoma at high risk for
recurrence following surgical resection The following patients are eligible: Resected
satellite or intransit metastasis with no evidence of residual disease OR Resected
solitary metastatic lesion(s) with no residual disease OR Metastatic melanoma with
measurable disease without noncutaneous lesion(s) greater than 5 cm in diameter OR Stage
III disease not eligible for interferon alfa therapy No active CNS disease

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: BUN less than 30 mg/dL
Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients
must use effective contraception HIV negative No prior or concurrent active peripheral
neuropathy No immunodeficiency disorder or immunodeficiency state No other prior or
concurrent malignancy, except: Curatively treated basal or squamous cell skin cancer
Carcinoma in situ of the cervix No hypersensitivity to GM-CSF, yeast derived products, or
any study component

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent
immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy and recovered No
more than 1 prior chemotherapy regimen as adjuvant or for metastatic disease No concurrent
chemotherapy Endocrine therapy: At least 2 weeks since prior glucocorticoids No concurrent
systemic corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and
recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least
30 days since other prior investigational drugs No concurrent immunosuppressive therapy
(e.g., cimetidine) No concurrent chronic antihistamine therapy