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Status unknownNCT00639925Updated Mar 14, 2013

Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

A Phase 1 interventional study of VEGFR1-1084, VEGFR2-169, and gemcitabine in Pancreatic Cancer, sponsored by Fukushima Medical University. Status unknown 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, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
5
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
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 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
04

Study design

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

Study arms

  • Experimental
    Phase I study

    Biological: VEGFR1-1084, VEGFR2-169, and 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.

05

What researchers measure

Primary outcomes

  1. Adverse effect, toxicities as assessed by NCI CTCAE version3.0

    Time frame: 3 months

Secondary outcomes

  1. feasibility

    Time frame: 2 years

06

Study locations

1 site
  • Fukushima Medical University Hospital
    Fukushima, 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 ↗
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Registry details

Key details

Study ID
NCT00639925
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
Mar 20, 2008
Start date
Mar 2007
Primary completion
Mar 2013 (estimated)
Completion
Mar 2013 (estimated)
Last update
Mar 14, 2013

Study contacts

Mitsukazu Gotoh, MD, PhD
study chair · Fukushima Medical University, First depertment of Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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