biological therapy in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. purpose: phase i/ii trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.

objectives: * assess the safety and toxicity of cellular adoptive immunotherapy using autologous cd8+ antigen-specific t-cell clones in patients with metastatic melanoma. * estimate the duration of in vivo persistence of adoptively transferred cd8+ antigen-specific cytotoxic t-cell clones in these patients. * evaluate the antitumor effects of cd8+ antigen-specific t-cell clones in these patients. outline: autologous peripheral blood mononuclear cells are harvested and then cd8+ cytotoxic t-lymphocyte (ctl) clones targeting melanosomal antigens are generated ex vivo. patients receive cellular adoptive immunotherapy comprising autologous cd8+ ctl clones over 30 minutes on day 1. patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. patients are followed for approximately 1 year after the last infusion. projected accrual: approximately 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histopathologically proven metastatic melanoma * no cns metastases * hla-a2 positive * bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, ct scan, or mri) * surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery patient characteristics: age * 18 to 75 performance status * karnofsky 80-100% life expectancy * more than 16 weeks hematopoietic * wbc greater than 4,000/mm\^3 * absolute neutrophil count greater than 2,000/mm\^3 * platelet count greater than 100,000/mm\^3 * hematocrit greater than 30% hepatic * bilirubin no greater than 1.6 mg/dl * sgot no greater than 150 iu (or no greater than 3 times normal) * prothrombin time no greater than 1.5 times control renal * creatinine no greater than 2.0 mg/dl * calcium no greater than 12 mg/dl cardiovascular * no congestive heart failure * no clinically significant hypotension * no symptoms of coronary artery disease * no arrhythmia on ekg requiring drug therapy pulmonary * no severe chronic obstructive pulmonary disease * fev_1 at least 1.0 l * dlco at least 45% of predicted other * no active infection or oral temperature greater than 38.2 degrees c within 72 hours of study * no systemic infection requiring chronic maintenance or suppressive therapy * hiv negative * no history of seizures * no retinitis or choroiditis * not pregnant or nursing * negative pregnancy test * fertile patients must use adequate contraception * peripheral blood samples available weekly for 4 consecutive weeks prior concurrent therapy: biologic therapy * at least 4 weeks since other prior immunotherapy chemotherapy * 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease * at least 4 weeks since prior standard or investigational chemotherapy endocrine therapy * at least 4 weeks since prior steroid therapy radiotherapy * at least 4 weeks since prior radiotherapy surgery * not specified other * at least 4 weeks since other prior investigational drug therapy and recovered

Keywords: stage iv melanoma recurrent melanoma