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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
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 may be a more effective treatment for metastatic melanoma of the eye. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 in treating patients who have metastatic melanoma of the eye.
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.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Surgery Branch
Bethesda, Maryland, United States
Start Date
February 1, 2001
Completion Date
March 1, 2007
Last Updated
March 4, 2024
gp100 antigen
DRUG
interleukin-2
DRUG
MART-1 antigen
DRUG
Montanide ISA-51
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT00121225
NCT01730157
Data Source & Attribution
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