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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00655785

Enrollment

Registered

2008-04-10

Start date

2007-09-30

Completion date

2013-03-31

Last updated

2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Epitope peptide, CTL, Pancreatic cancer, Vaccination VEGFR1, VEGFR2

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

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

DRUGGemcitabine

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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 uncured wound 6. Active or uncontrolled other malignancy 7. Steroids or immunosuppressing agent dependent status 8. Interstitial pneumonia 9. Ileus 10. Decision of unsuitableness by principal investigator or physician-in-charge

Design outcomes

Primary

Measure	Time frame
toxicities as assessed by NCI-CACAE ver3)	3 months

Secondary

Measure	Time frame
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration	3months
CD8 population	3months
Survival	1year
Objective response rate	1year
feasibility	1year
Change in level of regulatory T cells	3months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026