NCT00005629

Brief Summary

RATIONALE: Vaccines 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
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 1999

Typical duration 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

July 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 1, 2003

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

2.8 years

First QC Date

May 2, 2000

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)

  • Safety

    Determine the safety of intradermal injection of the hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ) peptides emulsified in Montanide ISA-51.

    1 month

Secondary Outcomes (2)

  • antigen-specific immune response

    1 month

  • Survival

    1 month

Study Arms (3)

Group A - first dosing group

EXPERIMENTAL

Patients will receive three biweekly intradermal vaccinations with four HLA-A\*0201-binding AFP-derived peptides (100 ug dose) emulsified in 2 ml of Montanide ISA-51.

Biological: AFP gene hepatocellular carcinoma vaccine

Arm B - dosing group 2

EXPERIMENTAL

Patients will receive three biweekly intradermal vaccinations with four HLA-A\*0201-binding AFP-derived peptides (500 ug dose) emulsified in 2 ml of Montanide ISA-51.

Biological: AFP gene hepatocellular carcinoma vaccine

Group 3 - dosing level 3

EXPERIMENTAL

Patients will receive three biweekly intradermal vaccinations with four HLA-A\*0201-binding AFP-derived peptides (1000 ug dose) emulsified in 2 ml of Montanide ISA-51.

Biological: AFP gene hepatocellular carcinoma vaccine

Interventions

AFP gene hepatocellular carcinoma vaccineBIOLOGICAL

Patients will receive three biweekly intradermal vaccinations with four HLA-A\*0201-binding AFP-derived peptides emulsified in 2 ml of Montanide ISA-51. Group A AFP peptide dose 100 ug Group B AFP peptide dose 500 ug Group C AFP peptide dose 1000 ug

Arm B - dosing group 2Group 3 - dosing level 3Group A - first dosing group

Eligibility Criteria

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

You may qualify if:

  • This study will enroll HLA-A 0201 adults over the age of 18 with history of biopsy-proven HCC and AFP positive by immunohistochemistry or serum AFP levels \> 2 times above the upper limit of normality. Any stage of disease will be eligible.
  • Both male and female patients may be enrolled. Females of childbearing potential must have a negative pregnancy test prior to treatment.
  • Patients must be ambulatory with a 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 evidence of opportunistic infection.
  • A minimum of 4 weeks must have elapsed since the completion of prior chemotherapy or radiation therapy.
  • Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
  • Hemoglobin \> 8.5 g/dl (patients cannot be transfusion dependent).
  • Platelets \> 30,000/mm3
  • WBC \> 2,000/mm3
  • Absolute Neutrophil Count (ANC) \> 1,000/mm3
  • Positive skin test to common antigens (tetanus and/or candida).
  • Ability to give informed consent and signed informed consent.

You may not qualify if:

  • Patients who meet any one of the following criteria will be excluded from study entry:
  • Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy. The ability to adequately respond to antigens will be tested before trial entry by requiring a positive response to skin allergens (tetanus and candida).
  • Lactating females: All patients must practice adequate birth control and females of child-bearing potential must have a negative serum HCG pregnancy test (within day -7 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, due to concerns in the ability to stimulate an effective immune response.
  • Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
  • Patients with any underlying conditions that would contraindicate therapy with study treatment (or allergies to reagents used in this study).
  • Patients with organ allografts.
  • Uncontrolled hepatic insufficiency and cirrhosis, Class C in the Child's classification, with bilirubin \> 3 mg/dl, albumin \< 3.0 g/dl, poorly controlled ascites, advanced encephalopathy and poor nutritional status.
  • Uncontrolled CNS metastasis. Patients with previously known CNS metastasis will be eligible if they have received CNS irradiation to control local tumor growth.
  • Concomitant Medication and Treatment:
  • All allowed medications or treatments should be kept to a minimum and recorded.
  • \- Concomitant Medications and Treatments Not Allowed: Corticosteroids, Cyclosporin A, cytotoxic chemotherapy.

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

October 1, 2003

Study Start

July 1, 1999

Primary Completion

May 1, 2002

Study Completion

June 1, 2002

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(1)