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Vaccine Therapy in Treating Patients With Liver Cancer
This study is ongoing, but not recruiting participants.
First Received: August 10, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Jonsson Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022334
  Purpose

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins 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
Biological: AFP gene hepatocellular carcinoma vaccine
Biological: therapeutic autologous dendritic cells
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma

Resource links provided by NLM:


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

Study Start Date: January 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A*0201-positive patients with hepatocellular carcinoma.
  • Determine the safety and toxicity of this regimen in these patients.
  • Determine the immunological effects of this regimen in these patients.
  • Determine the progression-free survival and clinical responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.

Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-18 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
  • Alpha-fetoprotein level greater than 30 ng/mL
  • HLA-A*0201 positive

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
  • Absolute neutrophil count greater than 1,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

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

Pulmonary:

  • Oxygen saturation at least 91% on room air
  • No dyspnea at rest

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception
  • HIV negative
  • No prior opportunistic infection
  • No congenital or acquired condition causing inability to generate immune response
  • Positive response to skin allergens
  • No acute viral, bacterial, or fungal infection requiring specific therapy
  • No underlying condition that would preclude study participation
  • No allergies to reagents used in study

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 corticosteroids

Radiotherapy:

  • Not specified

Surgery:

  • No prior organ allografts

Other:

  • At least 14 days since prior therapy for acute infection
  • No concurrent cyclosporine
  • No concurrent immunosuppressive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022334

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000068806, UCLA-0001026, NCI-G01-1997
Study First Received: August 10, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00022334     History of Changes
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

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 09, 2009