Vaccine Therapy in Treating Patients With Stage II, Stage IIIA, Stage IIIB, or Stage IVA Liver Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Biological: alpha fetoprotein adenoviral vector vaccine Biological: alpha fetoprotein plasmid DNA vaccine Biological: sargramostim plasmid DNA hepatocellular carcinoma vaccine adjuvant |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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) |
| Enrollment: | 0 |
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 followed by AFP adenoviral vector boost in patients with HLA-A*0201-expressing stage II-IVA hepatocellular carcinoma.
Secondary
- Determine the optimal biological dose of this regimen, as defined by the generation of AFP-specific immunity, in these patients.
- Determine disease-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of alpha fetoprotein (AFP) adenoviral vector boost.
Patients receive vaccination comprising AFP plasmid DNA and sargramostim (GM-CSF) plasmid DNA intramuscularly (IM) on days 1, 30, and 60 in the absence of unacceptable toxicity. Patients then receive boost immunization comprising AFP adenoviral vector IM and intradermally on day 90.
Cohorts of 3-6 patients receive escalating doses of AFP adenoviral vector boost until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00093548 History of Changes |
| Other Study ID Numbers: | CDR0000389221, UCLA-0302008-02 |
| Study First Received: | October 6, 2004 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized resectable adult primary liver cancer localized unresectable adult primary liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013