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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00093548
First received: October 6, 2004
Last updated: October 3, 2012
Last verified: October 2012
  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)

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Enrollment: 0
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 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093548

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Antoni Ribas, MD Jonsson Comprehensive Cancer Center
  More Information

No publications provided by Jonsson Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2014