Recurrent Melanoma, Stage III Melanoma, Stage IV Melanoma
Conditions
Keywords
adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma
Brief 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.
Detailed description
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone. II. Determine the benefits, risks, and side effects of these regimens in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms. Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10. Patients with stable or responding disease may receive additional courses every 28 days. Patients are followed every 4 months. PROJECTED ACCRUAL: A total of 280 patients (140 in each arm) will be accrued for this study.
Interventions
Sponsors
Vical
Study design
Primary purpose
TREATMENT
Eligibility
Age
18 Years to No maximum
Inclusion 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
Countries
United States
Outcome results
None listed