Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

Phase 1

• Conditions: Melanoma (Skin)

• Registration Number: NCT00037037
• Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Brief Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Detailed Description

OBJECTIVES:

* Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma.

* Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens.

* Compare tumor response in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6.

* Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days.

Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 months.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2002-05-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2004-05
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• 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)

Herbert Irving Comprehensive Cancer Center at Columbia University; 🇺🇸 New York, New York, United States