Vaccine Therapy in Treating Patients With Liver Cancer
- Conditions
- Liver Cancer
- Interventions
- Biological: AFP gene hepatocellular carcinoma vaccine
- Registration Number
- NCT00005629
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B - dosing group 2 AFP gene hepatocellular carcinoma vaccine Patients will receive three biweekly intradermal vaccinations with four HLA-A\*0201-binding AFP-derived peptides (500 ug dose) emulsified in 2 ml of Montanide ISA-51. Group A - first dosing group AFP gene hepatocellular carcinoma vaccine Patients will receive three biweekly intradermal vaccinations with four HLA-A\*0201-binding AFP-derived peptides (100 ug dose) emulsified in 2 ml of Montanide ISA-51. Group 3 - dosing level 3 AFP gene hepatocellular carcinoma vaccine Patients will receive three biweekly intradermal vaccinations with four HLA-A\*0201-binding AFP-derived peptides (1000 ug dose) emulsified in 2 ml of Montanide ISA-51.
- Primary Outcome Measures
Name Time Method Safety 1 month Determine the safety of intradermal injection of the hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ) peptides emulsified in Montanide ISA-51.
- Secondary Outcome Measures
Name Time Method antigen-specific immune response 1 month Determine the antigen-specific immune response to hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ), emulsified with Montanide ISA-51, in peripheral blood of patients with liver cancer.
Survival 1 month Determine the overall survival, disease-free survival or progression-free survival of patients with HCC vaccinated with hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ), emulsified with Montanide ISA-51.
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States