Vaccine Therapy in Treating Patients With Metastatic Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00019994
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
- Detailed Description
OBJECTIVES:
* Determine the clinical response to immunization using gp100:44-59 antigen peptide plus gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with metastatic melanoma who are HLA-DRB1\*0401 and HLA-A0201 positive.
* Determine the clinical response to immunization using gp100:44-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB1\*0401 positive but HLA-A0201 negative.
* Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment.
* Evaluate the toxicity profiles of these regimens in these patients.
OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100:209-217 (210M) antigen peptide immunization:
* Group 1 (HLA-A0201 positive and no prior gp100:209-217 \[210M\] antigen peptide): Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC.
* Group 2 (HLA-A0201 positive and prior gp100:209-217 \[210M\] antigen peptide): Patients receive treatment as in group 1.
* Group 3 (HLA-A0201 negative and no prior gp100:209-217 \[210M\] antigen peptide): Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone.
* All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients with complete response after 4 doses receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed, or partial response after 4 doses receive a maximum of 12 additional doses. Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization.
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States