Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
About this trial
This is an interventional treatment trial for Stage IV Melanoma focused on measuring adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma
Eligibility 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
Sites / Locations
- Mayo Clinic Cancer Center
- Roswell Park Cancer Institute
- Physician Reliance Network, Inc.