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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: 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
Drug: AFP gene hepatocellular carcinoma vaccine
Drug: therapeutic autologous dendritic cells
Phase I
Phase II

MedlinePlus related topics:   Cancer    Liver Cancer   

U.S. FDA Resources

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

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
National Cancer Institute (NCI)

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:   CDR0000068806, UCLA-0001026, NCI-G01-1997
First Received:   August 10, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00022334
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 Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Recurrence
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on December 03, 2008




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