Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Recurrent Melanoma, Stage IV Melanoma
About this trial
This is an interventional treatment trial for Recurrent Melanoma
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
Sites / Locations
- Cancer and Leukemia Group B
Arms of the Study
Arm 1
Experimental
Treatment (gp100:209-217, aldesleukin )
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 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 CR receive 3 additional courses after achieving CR.