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Vaccine Therapy in Treating Patients With Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AFP
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Hemoglobin >9.0g/dl Platelets >50000/mm3 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.

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

See intervention description.

Outcomes

Primary Outcome Measures

Dose limiting toxicity and maximum tolerable dose.

Secondary Outcome Measures

Generation of AFP specific immunity.
Progression-free survival.
clinical response in patients with measurable disease.

Full Information

First Posted
August 10, 2001
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00022334
Brief Title
Vaccine Therapy in Treating Patients With Liver Cancer
Official Title
A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
See intervention description.
Intervention Type
Biological
Intervention Name(s)
AFP
Other Intervention Name(s)
AFP peptide-pulsed autologous DC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose limiting toxicity and maximum tolerable dose.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Generation of AFP specific immunity.
Time Frame
3 years
Title
Progression-free survival.
Time Frame
3 years
Title
clinical response in patients with measurable disease.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Hemoglobin >9.0g/dl Platelets >50000/mm3 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S. Economou, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Liver Cancer

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