Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01266707
• Other study ID #: 560
• Status: Recruiting
• Phase: Phase 1
• First received: December 23, 2010
• Last updated: December 23, 2010
• Start date: March 2007
• Est. completion date: March 2013

Study information

• Verified date: December 2010
• Source: Fukushima Medical University
• Contact: Akira Kenjo, MD
• Phone: +81-24-547-1111
• Email: a-kenjo[@]fmu.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• antiangiogenic paptide vaccine
for drugs include administration time frame

Locations

Country	Name	City	State
Japan	Fukushima Medical University Hospital	Fukushima

Sponsors (2)

Lead Sponsor	Collaborator
Fukushima Medical University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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. — View 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. Epub 2002 Nov 4. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities as assessed by NCI-CACAE ver3		3 months	Yes
Secondary	Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration		3 months	No
Secondary	CD8 population		3 months	No
Secondary	Change in level of regulatory T cells		3 months	No
Secondary	Objective response rate		1 year	No
Secondary	Feasibility		1 year	No
Secondary	Survival		1 year	No

External Links

•   Fukushima Medical University (Department of Regeneration Surgery)