Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

December 23, 2010 updated by: Fukushima Medical University

Phase 1 Study of HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived Feom VEGFR1 and VEGFR2 in Treating Patients With Unresectable, Recurrent, or Metastatic Hepatocellular Carcinoma

The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It has been required to develop new treatment modalities for patients with advanced heptatocellular carcinoma. Immunotherapy is one of the encouraging modalities for patients. We have to assess its toxicities, clinical response and immune responsiveness.

Study Type

Interventional

Enrollment (Anticipated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Takashi Kimura, MD, PhD
  • Phone Number: 2332 +81-24-547-1111
  • Email: tkimura@fmu.ac.jp

Study Locations

  • Japan
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
        • Contact:
        • Contact:
          • Takashi Kimura, PhD & MD
          • Phone Number: 2332 +81-24-547-1111
          • Email: a-kenjo@fmu.ac.jp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unresectable or treatment-resistant patients with Hepatocellular carcinoma
  • Measurable disease by CT scan
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Laboratory values as follows: 2,000/mm3 < WBC <15,000/mm3, Platelet counts > 75,000/mm3, Total Bilirubin < 1.5 mg/dl, Asparate transaminase < 150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
  • HLA-A*2402
  • Able and willing to give valid written informed consent

Exclusion Criteria:

  • Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  • Brest-feeder
  • Active or uncontrolled infection
  • Steroids or immunosuppressing agent dependent status
  • Active or uncontrolled other malignancy
  • Serious or uncured wound
  • Decision of unsuitableness by principal investigator or physician-in charge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine
VEGRF1, VEGFR2
Biological: antiangiogenic paptide vaccine
for drugs include administration time frame
Other Names:
  • VEGFR1 and VEGFR2 specific epitope vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicities as assessed by NCI-CACAE ver3
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
CD8 population
Time Frame: 3 months
3 months
Change in level of regulatory T cells
Time Frame: 3 months
3 months
Objective response rate
Time Frame: 1 year
1 year
Feasibility
Time Frame: 1 year
1 year
Survival
Time Frame: 1 year
1 year
Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fukushima Medical University

Collaborators

Human Genome Center, Institute of Medical Science, University of Tokyo

Investigators

  • Study Chair: Mitsukazu Gotoh, PhD & MD, Fukushima Medical University, Department of Regeneration Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (Estimate)

December 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 24, 2010

Last Update Submitted That Met QC Criteria

December 23, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 560

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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