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Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fukushima Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Fukushima Medical University
ClinicalTrials.gov Identifier:
NCT01266707
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Biological: antiangiogenic paptide vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fukushima Medical University:

Primary Outcome Measures:
  • Toxicities as assessed by NCI-CACAE ver3 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • CD8 population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in level of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: March 2007
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
VEGRF1, VEGFR2
Biological: antiangiogenic paptide vaccine
for drugs include administration time frame
Other Name: VEGFR1 and VEGFR2 specific epitope vaccine

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01266707

Contacts
Contact: Akira Kenjo, MD +81-24-547-1111 ext 2332 a-kenjo@fmu.ac.jp
Contact: Takashi Kimura, MD, PhD +81-24-547-1111 ext 2332 tkimura@fmu.ac.jp

Locations
Japan
Fukushima Medical University Hospital Recruiting
Fukushima, Japan, 960-1295
Contact: Akira Kenjo, MD    +81-24-547-1111 ext 2332    a-kenjo@fmu.ac.jp   
Contact: Takashi Kimura, PhD & MD    +81-24-547-1111 ext 2332    a-kenjo@fmu.ac.jp   
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Mitsukazu Gotoh, PhD & MD Fukushima Medical University, Department of Regeneration Surgery
  More Information

Additional Information:
Publications:
Responsible Party: Fukushima Medical University
ClinicalTrials.gov Identifier: NCT01266707     History of Changes
Other Study ID Numbers: 560
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Fukushima Medical University:
Hepatocellular carcinoma
peptide vaccine
VEGFR

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

ClinicalTrials.gov processed this record on November 27, 2014