Vaccine Therapy in Treating Patients With Liver Cancer

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00005629
First received: May 2, 2000
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Biological: AFP gene hepatocellular carcinoma vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial Testing Alpha Fetoprotein (AFP) Peptide Immunization in Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • antigen-specific immune response [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determine the antigen-specific immune response to hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ), emulsified with Montanide ISA-51, in peripheral blood of patients with liver cancer.

  • Survival [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determine the overall survival, disease-free survival or progression-free survival of patients with HCC vaccinated with hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ), emulsified with Montanide ISA-51.


Enrollment: 6
Study Start Date: July 1999
Study Completion Date: June 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A - first dosing group
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

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

Experimental: Arm B - dosing group 2
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

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

Experimental: Group 3 - dosing level 3
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

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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005629

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: James S. Economou, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: James Economou, MD / Principal Investigator, UCLA
ClinicalTrials.gov Identifier: NCT00005629     History of Changes
Other Study ID Numbers: CDR0000067782, P30CA016042, UCLA-9905003, NCI-H00-0053
Study First Received: May 2, 2000
Last Updated: July 27, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
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:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 01, 2014