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