Study of gp75 Vaccine in Patients With Stage III and IV Melanoma

Inclusion Criteria

• •1. The patient has a diagnosis of American Joint Commission on Cancer (AJCC) stage 111 or IV malignant melanoma. A patient who is free of disease after surgical resection of stage 111 or IV disease, but at high risk (defined as a primary tumor \>4 rnm, satellite or in-transit lesions, one or more positive lymph nodes or distant metastases) for recurrence is also eligible. A patient with metastatic disease may have no more than five sites of disease. The skin represents one site regardless of the number of lesions. Stage 111 melanoma is defined as a pT4 primary tumor (\>4m in depth or Clark level 5) in-transit metastases, satellites lesions or regional lymph nodes involved with melanoma.Pathology slides must be reviewed by the investigational site's Department of Pathology.
• •2. The patient's Karnofsky performance status is 280 at study entry.
• •3. The patient has given signed informed consent.
• •4. The patient has had surgery for their melanoma at least 6 months prior to study entry, or has had prior interferon therapy, or developed unacceptable toxicities to interferon therapy, or has a pre-existing condition(s) that precludes the patient fkom receiving interferon treatment.
• •5. The patient is 21 8 years of age.
• •6. The patient must have completed any prior irradiation, chemotherapy, or systemic immunotherapy (interferon-alpha, or interleukin-2) at least 30 days prior to study entry.
• •7. The patient has adequate hematologic function as defined as a platelet count 2100,000/mm3 and white blood cell (WBC) level 23,000/mm3.
• •8. The patient has serum lactose dehydrogenase (LDH) within normal range and a serum creatinine level \<2.0 mg/dL.
• •9. The patient agrees to use effective contraception if procreative potential exists.