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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001439
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition Intervention Phase
Melanoma Biological: gp100 human melanoma peptide Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 255
Study Start Date: June 1995
Estimated Study Completion Date: April 2000
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001439


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001439     History of Changes
Other Study ID Numbers: 950145
95-C-0145
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: May 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer
Immunotherapy

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs