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Vaccine Therapy in Treating Patients With Liver Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005629
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.


Condition Intervention Phase
Liver Cancer
Drug: AFP gene hepatocellular carcinoma vaccine
Drug: incomplete Freund's adjuvant
Phase I
Phase II

MedlinePlus related topics: Cancer Liver Cancer
Drug Information available for: Freund's adjuvant Montanide ISA 51
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial Testing Alpha Fetoprotein (AFP) Peptide Immunization in Hepatocellular Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2000
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of human alpha fetoprotein (hAFP) peptide immunization comprised of hAFP(137-145), hAFP(158-166), hAFP(325-334), and hAFP(542-550) when emulsified in Montanide ISA-51 in HLA-A*0201 positive patients with hepatocellular carcinoma.
  • Determine the safety and toxicity of this regimen in these patients.
  • Determine the antigen-specific immune response, overall survival, disease free survival, and progression free survival in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive human alpha fetoprotein (hAFP) peptide immunization comprising hAFP(137-145), hAFP(158-166), hAFP(325-334), and hAFP(542-550) emulsified in Montanide ISA-51 intradermally into the proximal extremities or anterior trunk draining inguinal and axillary lymph nodes on days 0, 14, 28, and 42.

Cohorts of 3-6 patients receive escalating doses of hAFP peptide immunization until the maximum tolerated dose is determined (MTD). The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 24 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:

  • Histologically proven hepatocellular carcinoma

    • Any stage
  • HLA-A*0201 positive
  • Alpha fetoprotein (AFP) positive tumor by immunohistochemistry OR
  • AFP levels greater than 30 ng/mL
  • No organ allografts
  • No uncontrolled CNS metastasis

    • Patients with prior CNS metastasis are eligible if they have received prior CNS irradiation to control local tumor growth

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No history of New York Heart Association class III or IV cardiac insufficiency or coronary artery disease
  • No ischemic heart disease that would increase risk

Pulmonary:

  • No lung disease that would increase risk
  • No dyspnea at rest

Immunologic:

  • Positive skin test to common antigens (tetanus and candida)
  • No congenital or acquired condition leading to an inability to generate an immune response

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No opportunistic infection
  • No acute viral, bacterial, or fungal infection that requires specific therapy
  • HIV negative
  • No concurrent condition that would preclude study treatment
  • No allergy to reagents used in this study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified

Other:

  • At least 2 weeks since prior acute therapy for acute viral, bacterial, or fungal infection
  • No concurrent immunosuppressive therapy (e.g., cyclosporine)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005629

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: James S. Economou, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000067782, UCLA-9905003, NCI-H00-0053
Study First Received: May 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005629  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized resectable adult primary liver cancer
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Recurrence
Carcinoma
Liver Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Freund's Adjuvant
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009