Pancreatic Cancer
Conditions
Brief summary
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
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
Interventions
BIOLOGICALVEGFR1-1084, VEGFR2-169, and gemcitabine
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8 and 15.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Fukushima Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS 1\. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. Measurable disease by CT scan PATIENTS CHARACTERISTICS 1. ECOG performance status 0-2 2. Life expectancy \> 3 months 3. 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 4. HLA-A\*2402 5. Able and willing to give valid written informed consent
Exclusion criteria
1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breast-feeder 3. Active or uncontrolled infection 4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks 5. Serious or aggravated wound 6. Active or uncontrolled other malignancy 7. Steroids or immunosuppressing agent dependant status 8. Interstitial pneumonia 9. Ileus 10. Decision of unsuitableness by principal investigator or physician-in-charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effect, toxicities as assessed by NCI CTCAE version3.0 | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| feasibility | 2 years |
Countries
Japan
Outcome results
None listed