HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

Study Overview
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Brief Summary
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The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.

Detailed Description
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The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.

Official Title
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Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: VEGFR1, VEGFR2
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 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 count >75,000/mm3, Total Bilirubin <1.5 mg/dl, Asparate transaminase <150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl HLA-A*0201 Able and willing to give valid written infromed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breast-feeder Active or uncontrolled infection Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks Serious or uncured wound Active or uncontrolled other malignancy Steroids or immunosuppressing agent dependent status Interstitial pneumonia Ileus 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: Phase 1 study<br>Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine | Biological: VEGFR1, VEGFR2<br>* One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22<br>* Other names: VEGFR1 and VEGFR2 specific epitope vaccine;Drug: Gemcitabine<br>* Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.<br>* Other names: Gemzar;|

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 gemcitabine and 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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pancreatic cancer, peptide vaccine, VEGFR, gemcitabine