Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.

• Phase: Phase 3

Details

• Lead Sponsor: Vical
• Treatments: Dacarbazine

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option

• Dacarbazine is indicated as first line chemotherapy

• At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2

• No history of brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: At least 4 weeks since prior biologic therapy

• Chemotherapy: See Disease Characteristics; No 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 experimental therapy

--Patient Characteristics--

• Age: 18 and over

• Performance status: Karnofsky 80-100%

• Life expectancy: At least 24 weeks

• 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 (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN

• 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; Not pregnant or nursing; 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 within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders