Vaccine Therapy in Treating Patients With Stage II, Stage IIIA, Stage IIIB, or Stage IVA Liver Cancer
NCT ID: NCT00093548
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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alpha fetoprotein adenoviral vector vaccine
alpha fetoprotein plasmid DNA vaccine
sargramostim plasmid DNA hepatocellular carcinoma vaccine adjuvant
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Principal Investigators
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Antoni Ribas, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
References
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Butterfield LH, Economou JS, Gamblin TC, Geller DA. Alpha fetoprotein DNA prime and adenovirus boost immunization of two hepatocellular cancer patients. J Transl Med. 2014 Apr 5;12:86. doi: 10.1186/1479-5876-12-86.
Other Identifiers
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UCLA-0302008-02
Identifier Type: -
Identifier Source: secondary_id
CDR0000389221
Identifier Type: -
Identifier Source: org_study_id