Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

Phase 1

Completed

• Conditions: Intraocular Melanoma; Melanoma (Skin)
• Interventions: Biological: IFA; Biological: 6MHP; Biological: GM-CSF

• Registration Number: NCT00089219
• Lead Sponsor: University of Virginia

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

Detailed Description

OBJECTIVES:

* Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.

* Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

* Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Primary Completion: 2006-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A. 6MHP vaccine 200 mcg	GM-CSF	vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm A. 6MHP vaccine 200 mcg	IFA	vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm B. 6MHP vaccine 400 mcg	IFA	vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm C. 6MHP vaccine 800 mcg	6MHP	vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm C. 6MHP vaccine 800 mcg	GM-CSF	vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm A. 6MHP vaccine 200 mcg	6MHP	vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm B. 6MHP vaccine 400 mcg	6MHP	vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm B. 6MHP vaccine 400 mcg	GM-CSF	vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Arm C. 6MHP vaccine 800 mcg	IFA	vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)

Primary Outcome Measures

Name	Time	Method
Safety: Dose-limiting toxicity	During study period	Toxicities measured by CTCAE.
Immunogenicity	day 22	Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.

Secondary Outcome Measures

Name	Time	Method
Immune response in the blood	day 50	Immune response measured in the blood, by proliferation assay, over time during the study.
DTH response	by day 85	Delayed-type hypersensitivity response to tumor peptides
Clinical outcome	during the study	Clinical tumor response

Trial Locations

Locations (1)

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States