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Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT00003224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-11-20

Study results available
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Summary

RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

QS21

vaccine adjuvant

BIOLOGICAL

IFA (incomplete Freund's adjuvant)

Peptides emulsified in IFA.

BIOLOGICAL

p946

This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.

BIOLOGICAL

p946/tet-p

This peptide is a longer version of p946 (gp100 \[280-288\]) sythesized colinearly with the tetanus helper peptide (Tet-p)

BIOLOGICAL

Tet-p

modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Craig L. Slingluff, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-02-29
Primary Completion
2000-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003224 on ClinicalTrials.gov