A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Institute (NCI) | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7.
- Rosenberg SA. Cancer vaccines based on the identification of genes encoding cancer regression antigens. Immunol Today. 1997 Apr;18(4):175-82. Review.
- Rosenberg SA. Development of cancer immunotherapies based on identification of the genes encoding cancer regression antigens. J Natl Cancer Inst. 1996 Nov 20;88(22):1635-44. Review.
- 950145
- 95-C-0145