Status:
WITHDRAWN
Vaccine Therapy in Treating Patients With Stage II, Stage IIIA, Stage IIIB, or Stage IVA Liver Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of adjuvant vaccination comprising alpha fetoprotein (AFP) plasmid DNA and sargramostim (GM-CSF) plasmid DNA fol...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093548
Last Update
October 4 2012
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