Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00020397
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-01
• Study Completion: 2005-07
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States