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

• Status: Completed
• Trial end date: 2002-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vical

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