NCT01266707

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 24, 2010

Status Verified

December 1, 2010

Enrollment Period

5 years

First QC Date

December 23, 2010

Last Update Submit

December 23, 2010

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomapeptide vaccineVEGFR

Outcome Measures

Primary Outcomes (1)

  • Toxicities as assessed by NCI-CACAE ver3

    3 months

Secondary Outcomes (6)

  • Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration

    3 months

  • CD8 population

    3 months

  • Change in level of regulatory T cells

    3 months

  • Objective response rate

    1 year

  • Feasibility

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Vaccine

EXPERIMENTAL

VEGRF1, VEGFR2

Biological: antiangiogenic paptide vaccine

Interventions

antiangiogenic paptide vaccineBIOLOGICAL

for drugs include administration time frame

Also known as: VEGFR1 and VEGFR2 specific epitope vaccine
Vaccine

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 12415261BACKGROUND

  • 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.

    PMID: 17020992BACKGROUND

  • 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.

    PMID: 15930316BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Mitsukazu Gotoh, PhD & MD

    Fukushima Medical University, Department of Regeneration Surgery

    STUDY CHAIR

Central Study Contacts

Akira Kenjo, MD

CONTACT

+81-24-547-1111a-kenjo@fmu.ac.jp

Takashi Kimura, MD, PhD

CONTACT

+81-24-547-1111tkimura@fmu.ac.jp

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 24, 2010

Study Start

March 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

December 24, 2010

Record last verified: 2010-12

Locations

JP(1)