Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •-Disease Characteristics--
• •Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung
• •At least 1 metastasis for which surgery is not deemed to be a curative option
• •Relapsed from or has not responded to frontline chemotherapy or biotherapy
• •At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm
• •No history of brain metastases or visceral metastases other than lung metastases
• •-Prior/Concurrent Therapy--
• •Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy
• •Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy
• •Endocrine therapy: No concurrent immunosuppressive drugs
• •Radiotherapy: At least 4 weeks since prior radiotherapy
• •Surgery: At least 2 weeks since prior major surgery
• •Other: No other concurrent anticancer drug therapy, or any other experimental therapy
• •-Patient Characteristics--
• •Age: 18 and over
• •Performance status: Karnofsky 80-100%
• •Life expectancy: At least 6 months
• •Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
• •Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal; PT/PTT normal LDH and albumin normal
• •Renal: Creatinine no greater than 2.0 mg/dL
• •Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
• •Other: HIV negative; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy in the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders