A Randomized Phase II Trial of Multi-Epitope Vaccination With Melanoma Peptides For Cytotoxic T Cells And Helper T Cells For Patients With Metastatic Melanoma

NCT00071981 Phase 2 COMPLETED Results posted

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma.

Details

Lead sponsor	Eastern Cooperative Oncology Group
Phase	Phase 2
Status	COMPLETED
Enrolment	175
Start date	2005-05-09
Completion	2014-01

Conditions

• Melanoma (Skin)

Interventions

• incomplete Freund's adjuvant
• melanoma helper peptide vaccine
• multi-epitope melanoma peptide vaccine
• sargramostim
• tetanus peptide melanoma vaccine

Primary outcomes

• Cytotoxic T-cell Lymphocytes (CTL) Response Rate — Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8
  Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.

Countries

United States