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CompletedNCT00655785Updated Mar 14, 2013

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

A Phase 1/2 interventional study of VEGFR1-1084, VEGFR2-169 and Gemcitabine in Pancreatic Cancer, sponsored by Fukushima Medical University. Completed at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-03-14.

Sponsored by Fukushima Medical University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Epitope peptide
  • CTL
  • Pancreatic cancer
  • Vaccination VEGFR1
  • VEGFR2
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Phase 1/2 study

    Biological: VEGFR1-1084, VEGFR2-169 · Drug: 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

05

What researchers measure

Primary outcomes

  1. toxicities as assessed by NCI-CACAE ver3)

    Time frame: 3 months

Secondary outcomes

  1. Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration

    Time frame: 3months

  2. CD8 population

    Time frame: 3months

  3. Change in level of regulatory T cells

    Time frame: 3months

  4. Objective response rate

    Time frame: 1year

  5. feasibility

    Time frame: 1year

  6. Survival

    Time frame: 1year

06

Study locations

1 site
  • Fukushima Medical University Hospital
    Fukushima, 960-1295, Japan
07

References and documents

Publications

  • Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4. PubMed 12415261 ↗
  • Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750. PubMed 17020992 ↗
  • Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759. PubMed 15930316 ↗
08

Registry details

Key details

Study ID
NCT00655785
Lead sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
Responsible party
Takashi Kimura (Assistant professor, Fukushima Medical University) — Principal investigator
First posted
Apr 10, 2008
Start date
Sep 2007
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Mar 14, 2013

Study contacts

Mitsukazu Gotoh, M.D. & Ph.D
study chair · Fukushima Medical University, Department

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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