Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

Fecha de inicio: 1 de agosto de 1998

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