Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

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.

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