Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Detailed Description
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Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Official Title
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Phase Ｉ/Ⅱ Sturdy on Antiangiogenic 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: VEGFR1-1084, VEGFR2-169
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DISEASE CHARACTERISTICS Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer Measurable disease by CT scan PATIENTS CHARACTERISTICS ECOG performance status 0-2 Life expectancy > 3 months Laboratory values as follows: 2,000/mm3 < WBC < 15000/mm3 Platelet count ≥ 750,000/mm³ Total Bilirubin ≤ 1.5 x Aspartate transaminase < 150 IU/L Alanine transaminase < 150 IU/L Creatinine ≤ 3.0 mg/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) 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 1/2 study<br> | Biological: VEGFR1-1084, VEGFR2-169<br>* One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C<br>Drug: Gemcitabine<br>* Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17<br>|

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 |  | 3months | 
| CD8 population |  | 3months | 
| Change in level of regulatory T cells |  | 3months | 
| Objective response rate |  | 1year | 
| feasibility |  | 1year | 
| Survival |  | 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epitope peptide, CTL, Pancreatic cancer, Vaccination VEGFR1, VEGFR2