NCT00020475

Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Extraocular Extension Melanoma
• Recurrent Intraocular Melanoma

Interventions

Type	Name	Description
DRUG	gp100 antigen
DRUG	interleukin-2
DRUG	MART-1 antigen
DRUG	Montanide ISA-51

Timeline

• Start date: 2001-02-01
• Completion: 2007-03-01
• First posted: 2007-03-06
• Last updated: 2024-03-04

Locations

1 site across 1 country: United States