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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given SC
Given SC
Correlative studies
Cancer and Leukemia Group B
Chicago, Illinois, United States
Clinical response rate (CR or PR)
Time frame: From the start of treatment until disease progression/recurrence, assessed up to 3 years
Response duration
The Kaplan-Meier method will be used to estimate duration of response.
Time frame: Up to 3 years
Progression-free intervals
The Kaplan-Meier method will be used to estimate time to progression.
Time frame: Up to 3 years
Immunologic response rate using ELISPOT assay
Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.
Time frame: Up to 3 years
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