Liver Cancer Clinical Trial
Official title:
A Phase I/II Trial Testing Immunization With AFP + GM-CSF Plasmid Prime And AFP Adenoviral Vector Boost In Patients With Hepatocellular Carcinoma (AFP Prime-Boost Protocol)
Verified date | October 2012 |
Source | Jonsson Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Vaccines made from DNA and a gene-modified virus may make the body build an
immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune
response and prevent or delay the recurrence of liver cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy
and to see how well it works in treating patients with stage II, stage IIIA, stage IIIB, or
stage IVA liver cancer.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of hepatocellular carcinoma - Stage II-IVA disease - No active disease after local or regional therapy (e.g., surgical resection, radiofrequency ablation, cryoablation, or ethanol injection) - Serum alpha fetoprotein > upper limit of normal - HLA-A*0201 positive by DNA subtyping PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Hemoglobin > 9.0 g/dL (transfusion independent) - Platelet count > 50,000/mm^3 - Absolute neutrophil count > 1,000/mm^3 Hepatic - Child Pugh class A or B liver function - Hepatitis B or C viral infection allowed Renal - Not specified Cardiovascular - No New York Heart Association class III or IV cardiac insufficiency - No coronary artery disease Immunologic - HIV negative - No other acute viral, bacterial, or fungal infection requiring therapy - No allergy to study agents - No history of opportunistic infection - No high serum titer of neutralizing anti-adenoviral antibodies - No congenital or acquired condition resulting in an inability to generate an immune response Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective double-method (including a barrier method) contraception - No other condition that would preclude study participation 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 steroid therapy, including corticosteroids Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior organ allograft Other - At least 2 weeks since prior therapy for acute infection - No concurrent immunosuppressive therapy - No concurrent cyclosporine |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Jonsson Comprehensive Cancer Center | National Cancer Institute (NCI) |
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