Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: antiangiogenic paptide vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine<br>VEGRF1, VEGFR2 | Biological: antiangiogenic paptide vaccine<br>* for drugs include administration time frame<br>* Other names: VEGFR1 and VEGFR2 specific epitope vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities as assessed by NCI-CACAE ver3 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, peptide vaccine, VEGFR