NCT00019994

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	MART-1 antigen
BIOLOGICAL	aldesleukin
BIOLOGICAL	gp100 antigen
BIOLOGICAL	incomplete Freund's adjuvant

Timeline

• Start date: 1999-10-01
• Completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States