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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


Phase 2
N/A
N/A
Not Enrolling
Both
Melanoma, Neoplasm Metastasis

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Trial Information

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


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.

Inclusion 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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

980023

NCT ID:

NCT00001685

Start Date:

November 1997

Completion Date:

September 2000

Related Keywords:

  • Melanoma
  • Neoplasm Metastasis
  • Cancer
  • IL-12
  • IL-2
  • Immunotherapy
  • Vaccine
  • Neoplasms
  • Melanoma
  • Neoplasm Metastasis

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892