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


Phase 1
N/A
N/A
Not Enrolling
Both
Melanoma

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950145

NCT ID:

NCT00001439

Start Date:

June 1995

Completion Date:

April 2000

Related Keywords:

  • Melanoma
  • Cancer
  • Immunotherapy
  • Melanoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892