Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye
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.
|Extraocular Extension Melanoma Recurrent Intraocular Melanoma||Drug: gp100 antigen Drug: interleukin-2 Drug: MART-1 antigen Drug: Montanide ISA-51||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||February 2001|
|Study Completion Date:||March 2007|
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.
A total of 15-25 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020475
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Francesco M. Marincola||National Cancer Institute (NCI)|