NCT00020397

Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen

• 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: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.

Detailed description

OBJECTIVES: * Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A\*201 or HLA-DPB1\*04 positive patients with refractory metastatic melanoma expressing ESO-1. * Determine the toxicity of this vaccine in these patients. * Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2. OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type. * Group 1 (HLA-A\*201 and HLA-DPB1\*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 \[165V\]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. * Group 2 (HLA-A\*201 positive and HLA-DPB1\*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only. * Group 3 (HLA-A\*201 negative and HLA-DPB1\*04 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only. Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity. Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy. Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	NY-ESO-1 peptide vaccine
BIOLOGICAL	aldesleukin

Timeline

• Start date: 2000-11-01
• Completion: 2005-07-01
• First posted: 2003-01-27
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States