Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01266707
Recruitment Status : Unknown
Verified December 2010 by Fukushima Medical University.
Recruitment status was:  Recruiting
First Posted : December 24, 2010
Last Update Posted : December 24, 2010
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Fukushima Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: antiangiogenic paptide vaccine Phase 1

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  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: Vaccine
Biological: antiangiogenic paptide vaccine
for drugs include administration time frame
Other Name: VEGFR1 and VEGFR2 specific epitope vaccine

Primary Outcome Measures :
  1. Toxicities as assessed by NCI-CACAE ver3 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration [ Time Frame: 3 months ]
  2. CD8 population [ Time Frame: 3 months ]
  3. Change in level of regulatory T cells [ Time Frame: 3 months ]
  4. Objective response rate [ Time Frame: 1 year ]
  5. Feasibility [ Time Frame: 1 year ]
  6. Survival [ Time Frame: 1 year ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01266707

Contact: Akira Kenjo, MD +81-24-547-1111 ext 2332
Contact: Takashi Kimura, MD, PhD +81-24-547-1111 ext 2332

Fukushima Medical University Hospital Recruiting
Fukushima, Japan, 960-1295
Contact: Akira Kenjo, MD    +81-24-547-1111 ext 2332   
Contact: Takashi Kimura, PhD & MD    +81-24-547-1111 ext 2332   
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Mitsukazu Gotoh, PhD & MD Fukushima Medical University, Department of Regeneration Surgery

Responsible Party: Fukushima Medical University Identifier: NCT01266707     History of Changes
Other Study ID Numbers: 560
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: December 24, 2010
Last Verified: December 2010

Keywords provided by Fukushima Medical University:
Hepatocellular carcinoma
peptide vaccine

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Angiogenesis Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents