gene therapy in treating patients with stage iii or stage iv melanoma

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

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.

objectives: i. demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage iii or iv melanoma treated with allovectin-7. allovectin-7 is a direct gene transfer immunotherapeutic agent. ii. determine the benefits, risks, and side effects of allovectin-7 in this patient population. protocol outline: this is a multicenter study. patients receive an intratumoral injection of allovectin-7 once weekly for 6 weeks. at week 9, a complete disease status assessment is performed. patients with stable or responding disease may receive additional courses of 6 injections. projected accrual: a total of 70 patients will be accrued for this study.

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

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