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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005629 |
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.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: AFP gene hepatocellular carcinoma vaccine Drug: incomplete Freund's adjuvant |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial Testing Alpha Fetoprotein (AFP) Peptide Immunization in Hepatocellular Carcinoma |
Study Start Date: | January 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven hepatocellular carcinoma
No uncontrolled CNS metastasis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | James S. Economou, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067782, UCLA-9905003, NCI-H00-0053 |
Study First Received: | May 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005629 |
Health Authority: | United States: Federal Government |
localized resectable adult primary liver cancer localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Recurrence Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Freund's Adjuvant Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |