chemotherapy with or without immunotherapy in treating patients with stage iii or stage iv melanoma

Conditions: Stage IV Melanoma; Stage III Melanoma; Recurrent Melanoma

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.

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.

Eligibility 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

Keywords: adult solid tumor body system/site cancer cancer melanoma recurrent melanoma skin tumor solid tumor stage iii melanoma stage iv melanoma stage, melanoma