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Pancreatic CancerPhase 1/2NCT00655785

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

A Phase 1/2 study testing VEGFR1-1084, VEGFR2-169 and Gemcitabine in people with Pancreatic Cancer, run by Fukushima Medical University at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
VEGFR1-1084, VEGFR2-169 and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteJapan
Study dates
Sep 2007to Mar 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Steroids or immunosuppressing agent dependent status
  • Interstitial pneumonia
  • Ileus
  • Decision of unsuitableness by principal investigator or physician-in-charge

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

Other trials in Japan

About this study

Official title: 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

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

Being tested
VEGFR1-1084, VEGFR2-169, Gemcitabine
Keywords
Epitope peptide, CTL, Pancreatic cancer, Vaccination VEGFR1, VEGFR2
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VEGFR1-1084, VEGFR2-169Biological

    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

  • GemcitabineDrug

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

Study groups in NCT00655785
Study groupRoleWhat they receive
Phase 1/2 studyExperimentalNot described
Receives: Biological: VEGFR1-1084, VEGFR2-169; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. toxicities as assessed by NCI-CACAE ver3)

    Measured: 3 months

Secondary outcomes (6)

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

    Measured: 3months

  2. CD8 population

    Measured: 3months

  3. Change in level of regulatory T cells

    Measured: 3months

  4. Objective response rate

    Measured: 1year

  5. feasibility

    Measured: 1year

  6. Survival

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00655785
Sponsor's protocol ID
FPCR1R2-2
Status last verified
Mar 2013
First submitted
4 Apr 2008
Last updated
14 Mar 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VEGFR1-1084, VEGFR2-169 and Gemcitabine in people with Pancreatic Cancer, run by Fukushima Medical University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

toxicities as assessed by NCI-CACAE ver3) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00655785, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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