NCT00093548

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 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

First QC Date

October 6, 2004

Last Update Submit

October 3, 2012

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomaadvanced adult primary liver cancerlocalized resectable adult primary liver cancerlocalized unresectable adult primary liver cancer

Interventions

alpha fetoprotein adenoviral vector vaccineBIOLOGICAL
alpha fetoprotein plasmid DNA vaccineBIOLOGICAL
sargramostim plasmid DNA hepatocellular carcinoma vaccine adjuvantBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24708667DERIVED

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Antoni Ribas, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Last Updated

October 4, 2012

Record last verified: 2012-10