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Vaccine Therapy in Treating Patients With Liver Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Vaccine Therapy in Treating Patients With Liver Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Liver Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Liver Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Vaccine Therapy in Treating Patients With Liver Cancer. Vaccine Therapy in Treating Patients With Liver Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Liver Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Vaccine Therapy in Treating Patients With Liver Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Liver Cancer  Vaccine Therapy in Treating Patients With Liver Cancer
Vaccine Therapy in Treating Patients With Liver Cancer
For Condition: localized resectable adult primary liver cancer,adult primary hepatocellular carcinoma,advanced adult primary liver cancer,localized unresectable adult primary liver cancer,recurrent adult primary liver cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins 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.
Details: OBJECTIVES: - Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A*0201-positive patients with hepatocellular carcinoma. - Determine the safety and toxicity of this regimen in these patients. - Determine the immunological effects of this regimen in these patients. - Determine the progression-free survival and clinical responses in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity. Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity. Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of hepatocellular carcinoma - Alpha-fetoprotein level greater than 30 ng/mL - HLA-A*0201 positive PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Hemoglobin greater than 9.0 g/dL (transfusion independent) - Platelet count greater than 50,000/mm^3 - Absolute neutrophil count greater than 1,000/mm^3 Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No New York Heart Association class III or IV cardiac insufficiency - No coronary artery disease Pulmonary: - Oxygen saturation at least 91% on room air - No dyspnea at rest Other: - Not pregnant - Negative pregnancy test - Fertile patients must use 2 methods of effective contraception - HIV negative - No prior opportunistic infection - No congenital or acquired condition causing inability to generate immune response - Positive response to skin allergens - No acute viral, bacterial, or fungal infection requiring specific therapy - No underlying condition that would preclude study participation - No allergies to reagents used in study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 30 days since prior chemotherapy - No concurrent cytotoxic chemotherapy Endocrine therapy: - At least 30 days since prior steroid therapy - No concurrent corticosteroids Radiotherapy: - Not specified Surgery: - No prior organ allografts Other: - At least 14 days since prior therapy for acute infection - No concurrent cyclosporine - No concurrent immunosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesEconomou, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Antoni Ribas 310-206-3928
Additional Information:
Study ID Numbers: CDR0000068806; NCI-G01-1997,UCLA-0001026
Study Start Date:
Record last reviewed: August 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022334
Other Localized Resectable Adult Primary Liver Cancer Studies:
1. Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
2. DX-8951f in Treating Patients With Liver Cancer
3. Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
4. Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
5. Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
Related Studies:
Other localized resectable adult primary liver cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy in Treating Patients With Liver Cancer
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