Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00019994
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.
Study:
NCT00019994
Study Brief:
Protocol Section:
NCT00019994