Clinical trial NCT01266707: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
peptide vaccine
VEGFR
Lead sponsor: Fukushima Medical University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2010-12-24
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Toxicities as assessed by NCI-CACAE ver3
timeFrame: 3 months
Secondary outcomes:
measure: Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration
timeFrame: 3 months
measure: CD8 population
timeFrame: 3 months
measure: Change in level of regulatory T cells
timeFrame: 3 months
measure: Objective response rate
timeFrame: 1 year
measure: Feasibility
timeFrame: 1 year
measure: Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
Study officials:
affiliation: Fukushima Medical University, Department of Regeneration Surgery
name: Mitsukazu Gotoh, PhD & MD
role: STUDY_CHAIR
References:
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.
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.
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.