Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
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
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate (CR or PR)
From the start of treatment until disease progression/recurrence, assessed up to 3 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Cancer and Leukemia Group B||Chicago, Illinois 60606|