Phase II Study of gp100:209-217 (210M) Antigen and MART-1:26-35 (27L) Antigen Emulsified in Montanide ISA-51 in Patients With Metastatic Ocular Melanoma
OBJECTIVES: I. Determine the clinical response in patients with metastatic ocular melanoma
treated with gp100:209-217 (210M) antigen and MART-1:26-35 (27L) antigen emulsified in
Montanide ISA-51.
II. Determine the clinical benefit of interleukin-2 in combination with this vaccine in
these patients.
PROTOCOL OUTLINE: Patients receive vaccine subcutaneously once weekly. Treatment repeats
every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable
toxicity.
Patients with progressive disease may receive vaccine SC on day 1 followed by interleukin-2
IV over 15 minutes every 8 hours for a maximum of 12 doses. Treatment repeats every 3 weeks
for at least 4 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL:
A total of 15-25 patients will be accrued for this study within 1 year.
Interventional
Primary Purpose: Treatment
Francesco M. Marincola
Study Chair
National Cancer Institute (NCI)
United States: Federal Government
CDR0000068514
NCT00020475
February 2001
Name | Location |
---|---|
Surgery Branch | Bethesda, Maryland 20892 |