vaccine plus interleukin-2 in treating patients with advanced melanoma

Conditions: Recurrent Melanoma; Stage IV Melanoma

Summary: phase ii trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. interleukin-2 may stimulate a person's white blood cells to kill cancer cells. melanoma vaccine plus interleukin-2 may kill more cancer cells

primary objectives: i. determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210m) melanoma vaccine and low-dose interleukin-2. ii. assess response duration and progression-free intervals in these patients receiving this treatment. outline: patients receive gp100:209-217(210m) emulsified in montanide isa-51 subcutaneously (sc) on day 1 and interleukin-2 sc on days 1-5 and 8-13. courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. patients with a complete response (cr) receive 3 additional courses after achieving cr. patients are followed every 9 weeks for 3 years or until disease recurrence. projected accrual: a total of 25-50 patients will be accrued for this study within 3.5 years.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed cutaneous melanoma with clinical evidence of distant, metastatic, unresectable regional lymphatic, or extensive in-transit recurrent disease * hla-a2\*0201 positive by genotyping * measurable disease as defined by the following: * at least 1 lesion accurately measured in at least 1 dimension * at least 20 mm by conventional techniques * at least 10 mm by spiral ct scan * lesions considered intrinsically nonmeasurable include: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * inflammatory breast disease * lymphangitis cutis/pulmonis * abdominal masses not confirmed and followed by imaging techniques * cystic lesions * lesions situated in a previously irradiated area * no ocular or mucosal melanoma * no prior or concurrent liver or brain metastases * performance status - ecog 0-1 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10 g/dl * ldh normal * bilirubin normal * ast no greater than 2.5 times upper limit of normal * creatinine normal * no congestive heart failure, angina, or symptomatic cardiac arrhythmia * no myocardial infarction within the past 6 months * no severe chronic pulmonary disease * not pregnant or nursing * fertile patients must use effective contraception * no primary or secondary immunodeficiency or autoimmune disease * no currently active second malignancy (e.g., patient has completed therapy and is considered unlikely to have recurrence within 1 year) other than nonmelanoma skin cancer * at least 4 weeks since prior immunotherapy * no prior interleukin-2 * no prior whole cell or gp100:209-217(210m)-targeted melanoma vaccine * no other concurrent cytokines or growth factors * at least 4 weeks since prior chemotherapy * at least 1 month since prior systemic corticosteroids * no concurrent systemic, inhaled, or topical corticosteroids * at least 1 month since other prior immunosuppressive medication * no antihypertensive medications from 1 day prior until 2 days after first course