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Vaccine Therapy in Treating Patients With Liver Cancer

2014-08-27 03:57:44 | BioPortfolio

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.

Description

OBJECTIVES:

- Determine the maximum tolerated dose of human alpha fetoprotein (hAFP) peptide immunization comprised of hAFP(137-145), hAFP(158-166), hAFP(325-334), and hAFP(542-550) when emulsified in Montanide ISA-51 in HLA-A*0201 positive patients with hepatocellular carcinoma.

- Determine the safety and toxicity of this regimen in these patients.

- Determine the antigen-specific immune response, overall survival, disease free survival, and progression free survival in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive human alpha fetoprotein (hAFP) peptide immunization comprising hAFP(137-145), hAFP(158-166), hAFP(325-334), and hAFP(542-550) emulsified in Montanide ISA-51 intradermally into the proximal extremities or anterior trunk draining inguinal and axillary lymph nodes on days 0, 14, 28, and 42.

Cohorts of 3-6 patients receive escalating doses of hAFP peptide immunization until the maximum tolerated dose is determined (MTD). The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

AFP gene hepatocellular carcinoma vaccine, incomplete Freund's adjuvant

Location

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles
California
United States
90095-1781

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:44-0400

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Medical and Biotech [MESH] Definitions

An ORTHOHEPADNAVIRUS causing chronic liver disease and hepatocellular carcinoma in woodchucks. It closely resembles the human hepatitis B virus.

A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested.

The founding member of the EPH FAMILY RECEPTORS. It was first cloned from an erythropoietin-producing human hepatocellular carcinoma cell line and is highly conserved among many mammalian species. Overproduction of the EphA1 receptor is associated with tumors and tumor cells of epithelial origin. It is also expressed at high levels in LIVER; LUNG; and KIDNEY; which is in contrast to many other members of the Eph receptor that are found primarily in tissues of the nervous system.

An antigen solution emulsified in mineral oil. The complete form is made up of killed, dried mycobacteria, usually M. tuberculosis, suspended in the oil phase. It is effective in stimulating cell-mediated immunity (IMMUNITY, CELLULAR) and potentiates the production of certain IMMUNOGLOBULINS in some animals. The incomplete form does not contain mycobacteria.

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

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