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

Tracking Information

First Received Date ^ICMJE

December 23, 2010

Last Updated Date

December 23, 2010

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatocellular Carcinoma

Intervention ^ICMJE

Biological: antiangiogenic paptide vaccine

for drugs include administration time frame

Other Name: VEGFR1 and VEGFR2 specific epitope vaccine

Study Arm (s)

Experimental: Vaccine

VEGRF1, VEGFR2

Intervention: Biological: antiangiogenic paptide vaccine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01266707

Other Study ID Numbers ^ICMJE

560

Has Data Monitoring Committee

Yes

Responsible Party

Fukushima Medical University

Study Sponsor ^ICMJE

Fukushima Medical University

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

Mitsukazu Gotoh, PhD & MD

Fukushima Medical University, Department of Regeneration Surgery

Information Provided By

Fukushima Medical University

Verification Date

December 2010

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

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