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

December 23, 2010
December 23, 2010
March 2007
March 2012   (final data collection date for primary outcome measure)
Toxicities as assessed by NCI-CACAE ver3 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma
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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
Biological: antiangiogenic paptide vaccine
for drugs include administration time frame
Other Name: VEGFR1 and VEGFR2 specific epitope vaccine
Experimental: Vaccine
VEGRF1, VEGFR2
Intervention: Biological: antiangiogenic paptide vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
March 2013
March 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
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
Japan
 
NCT01266707
560
Yes
Fukushima Medical University
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
Fukushima Medical University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP