Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye
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|ClinicalTrials.gov Identifier: NCT00020475|
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : August 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Extraocular Extension Melanoma Recurrent Intraocular Melanoma||Drug: gp100 antigen Drug: interleukin-2 Drug: MART-1 antigen Drug: Montanide ISA-51||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Study Completion Date :||March 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020475
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Francesco M. Marincola||National Cancer Institute (NCI)|