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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001439 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: gp100 human melanoma peptide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant |
| Estimated Enrollment: | 255 |
| Study Start Date: | June 1995 |
| Estimated Study Completion Date: | April 2000 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
| Study ID Numbers: | 950145, 95-C-0145 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001439 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cancer Immunotherapy |
|
Neoplasms by Histologic Type Immunologic Factors Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Freund's Adjuvant |
