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

August 10, 2001
February 6, 2009
January 2001
 
 
 
Complete list of historical versions of study NCT00022334 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Liver Cancer
A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma

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.

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.

Phase I, Phase II
Interventional
Treatment
Liver Cancer
  • Biological: AFP gene hepatocellular carcinoma vaccine
  • Biological: therapeutic autologous dendritic cells
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022334
 
CDR0000068806, UCLA-0001026, NCI-G01-1997
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: James S. Economou, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP