Vaccine Therapy in Treating Patients With Liver Cancer - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
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	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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:

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Dose limiting toxicity and maximum tolerable dose. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Generation of AFP specific immunity. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Progression-free survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
clinical response in patients with measurable disease. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	33
Study Start Date:	January 2001
Study Completion Date:	October 2008
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment See intervention description.	Biological: AFP Increasing doses of AFP will be given to groups of 3 intradermally. Subjects will receive 3 biweekly vaccinations. At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated. Other Name: AFP peptide-pulsed autologous DC

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

Inclusion Criteria:

HLA-A*0201 positive adults over the age of 18.
Have HCC with a serum AFP determination >30ng/ml.
Both male and female patients may be enrolled.
Karnofsky Performance Status greater than or equal to 70 percent.
No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
No previous evidence of opportunistic infection.
Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:
1. Hemoglobin >9.0g/dl
2. Platelets >50000/mm3
3. Absolute Neutrophil Count >1,000/mm3
Child-Pugh Class A or B for chronic liver disease.
Ability to give informed consent.

Exclusion Criteria:

Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.
Concomitant steroid therapy or chemotherapy, or any of these other treatments < 30 days before the first vaccination.
Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 to Day 0).
Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
HIV-infected patients.
Patients with any underlying conditions which would contraindicate therapy with study treatment.
Patients with organ allografts.
O2 sat <91% on room air; dyspnea at rest.

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

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Principal Investigator:

James S. Economou, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	James Economou, MD, UCLA
ClinicalTrials.gov Identifier:	NCT00022334 History of Changes
Other Study ID Numbers:	CDR0000068806, P30CA016042, UCLA-0001026, NCI-G01-1997
Study First Received:	August 10, 2001
Last Updated:	February 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

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
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases

Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 12, 2012