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Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase

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ClinicalTrials.gov Identifier: NCT00001685
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.

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


Condition or disease Intervention/treatment Phase
Melanoma Neoplasm Metastasis Biological: Immunodominant peptides from three melanoma antigens, MART-1, GP100 and tyrosinase Phase 2

Detailed Description:

This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.

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


Study Type : Interventional  (Clinical Trial)
Enrollment : 114 participants
Primary Purpose: Treatment
Official Title: Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
Study Start Date : November 1997
Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma





Information from the National Library of Medicine

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

Any patient 16 years of age or older with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months.

Must be HLA-A0201.

Serum creatinine of 2.0 mg/dl or less.

Bilirubin 1.6 mg/dl or less.

WBC 3000/mm(3) or greater.

Platelet count 90,000 mm(3) or greater.

Serum AST/ALT less then two times normal.

ECOG performance status of 0 or 1.

Patients of both genders must be willing to practice effective birth control during the trial.

Must not be undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer.

Must not have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.

Must not require steroid therapy.

Must not be pregnant.

Must not be positive for hepatitis B(s)AG or HIV antibody.

Must not have had a known allergic reaction to Incomplete Freund's Adjuvant (IFA).


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): NCT00001685


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

Publications:
ClinicalTrials.gov Identifier: NCT00001685     History of Changes
Other Study ID Numbers: 980023
98-C-0023
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: October 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer
IL-12
IL-2
Immunotherapy
Vaccine

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Vaccines
Immunologic Factors
Physiological Effects of Drugs