Vaccine Therapy in Treating Patients With Stage II, Stage IIIA, Stage IIIB, or Stage IVA Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093548
Recruitment Status : Withdrawn
First Posted : October 8, 2004
Last Update Posted : October 4, 2012
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment 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

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Hemoglobin > 9.0 g/dL (transfusion independent)
  • Platelet count > 50,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3


  • Child Pugh class A or B liver function
  • Hepatitis B or C viral infection allowed


  • Not specified


  • No New York Heart Association class III or IV cardiac insufficiency
  • No coronary artery disease


  • 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


  • 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


Biologic therapy

  • Not specified


  • 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


  • Not specified


  • See Disease Characteristics
  • No prior organ allograft


  • At least 2 weeks since prior therapy for acute infection
  • No concurrent immunosuppressive therapy
  • No concurrent cyclosporine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093548

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Antoni Ribas, MD Jonsson Comprehensive Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00093548     History of Changes
Other Study ID Numbers: CDR0000389221
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

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:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Immunologic Factors
Physiological Effects of Drugs