NCT00022334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

3.9 years

First QC Date

August 10, 2001

Last Update Submit

July 30, 2020

Conditions

Liver Cancer

Keywords

localized resectable adult primary liver cancerlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver canceradult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity and maximum tolerable dose.

    1 year

Secondary Outcomes (3)

  • Generation of AFP specific immunity.

    3 years

  • Progression-free survival.

    3 years

  • clinical response in patients with measurable disease.

    3 years

Study Arms (1)

Treatment

EXPERIMENTAL

See intervention description.

Biological: AFP

Interventions

AFPBIOLOGICAL

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.

Also known as: AFP peptide-pulsed autologous DC
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • James S. Economou, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

January 1, 2001

Primary Completion

December 1, 2004

Study Completion

October 1, 2008

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(1)