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Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
antiangiogenic paptide vaccine
Sponsored by
Fukushima Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, peptide vaccine, VEGFR

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fukushima Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine

Arm Description

VEGRF1, VEGFR2

Outcomes

Primary Outcome Measures

Toxicities as assessed by NCI-CACAE ver3

Secondary Outcome Measures

Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration
CD8 population
Change in level of regulatory T cells
Objective response rate
Feasibility
Survival

Full Information

First Posted
December 23, 2010
Last Updated
December 23, 2010
Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT01266707
Brief Title
Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, peptide vaccine, VEGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaccine
Arm Type
Experimental
Arm Description
VEGRF1, VEGFR2
Intervention Type
Biological
Intervention Name(s)
antiangiogenic paptide vaccine
Other Intervention Name(s)
VEGFR1 and VEGFR2 specific epitope vaccine
Intervention Description
for drugs include administration time frame
Primary Outcome Measure Information:
Title
Toxicities as assessed by NCI-CACAE ver3
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration
Time Frame
3 months
Title
CD8 population
Time Frame
3 months
Title
Change in level of regulatory T cells
Time Frame
3 months
Title
Objective response rate
Time Frame
1 year
Title
Feasibility
Time Frame
1 year
Title
Survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akira Kenjo, MD
Phone
+81-24-547-1111
Ext
2332
Email
a-kenjo@fmu.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Takashi Kimura, MD, PhD
Phone
+81-24-547-1111
Ext
2332
Email
tkimura@fmu.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsukazu Gotoh, PhD & MD
Organizational Affiliation
Fukushima Medical University, Department of Regeneration Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Kenjo, MD
Phone
+81-24-547-1111
Ext
2332
Email
a-kenjo@fmu.ac.jp
First Name & Middle Initial & Last Name & Degree
Takashi Kimura, PhD & MD
Phone
+81-24-547-1111
Ext
2332
Email
a-kenjo@fmu.ac.jp

12. IPD Sharing Statement

Citations:
PubMed Identifier
12415261
Citation
Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.
Results Reference
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PubMed Identifier
17020992
Citation
Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
Results Reference
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PubMed Identifier
15930316
Citation
Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
Results Reference
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Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

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