A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant

March 3, 2008 updated by: National Cancer Institute (NCI)

This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.

Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.

Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.

Study Type

Interventional

Enrollment

255

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Metastatic melanoma that is HLA-A2 positive.

No primary melanoma of ocular or mucosal origin.

Measurable or resected metastatic disease required.

PRIOR/CONCURRENT THERAPY:

BIOLOGIC THERAPY: No prior (greater than 30 days) or concurrent Biologic Therapy.

CHEMOTHERAPY: No prior (greater than 30 days) or concurrent chemotherapy.

ENDOCRINE THERAPY: No prior (greater than 30 days) or concurrent hormone therapy.

No requirement for steroids.

RADIOTHERAPY: No prior (greater than 30 days) or concurrent radiotherapy.

SURGERY: Not specified.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance Status: ECOG 0 or 1.

Life Expectancy: More than 3 months.

HEMATOPOIETIC: No coagulation disorder.

HEPATIC:

Bilirubin no greater than 2.0 mg/dL.

No Hepatitis BsAg antibody.

RENAL: Creatinine no greater than 2.0 mg/dL.

CARDIOVASCULAR: No major cardiovascular illness.

PULMONARY: No major respiratory illness.

OTHER:

No previous allergic reaction to incomplete Freund's adjuvant.

HIV negative.

No active systemic infection.

Not pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1995

Primary Completion

December 7, 2022

Study Completion

April 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

May 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 950145
  • 95-C-0145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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