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Pancreatic CancerPhase 1NCT00622622

Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer

A Phase 1 study testing VEGFR2-169 and gemcitabine in people with Pancreatic Cancer, run by Wakayama 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, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose. 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?
VEGFR2-169 and gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteJapan
Study dates
Nov 2006to Feb 2009
Phase
Phase 1
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
  • PATIENT CHARACTERISTICS
  • ECOG performance status 0-2
  • Life expectancy > 3 months
Show all 15Show fewer
  • Laboratory values as follows
  • 2000/mm3 < WBC < 15000/mm3
  • Platelet count > 75000/mm3
  • Bilirubin < 3.0 mg/dl
  • 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(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Active or uncontrolled infection
  • Concurrent treatment with steroids or immunosuppressing agent
  • Prior chemotherapy of gemcitabine
  • Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
Show all 11Show fewer
  • Serious or nonhealing wound, ulcer, or bone fracture
  • Active or uncontrolled other malignancy
  • Ileus
  • Interstitial pneumonia
  • Decision of unsuitableness by principal investigator or physician-in-charge

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Wakayama Medical University Hospital

    811-1 Kimiidera, Wakayama, Wakayama

Other trials in Japan

About this study

Official title: Phase I Study of Gemcitabine With Antiangiogenic Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 Derived From VEGFR2 in Patients With Unresectable, Locally Advanced, Recurrent or Metastatic Pancreatic Cancer

The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.

Read the detailed description

Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.

Being tested
VEGFR2-169 and gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • VEGFR2-169 and gemcitabineBiological

    Escalating doses of VEGFR2-169 will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles(doses of 0.5,1.0,2.0mg/body are planned). Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days 1,8 and 15. Repeated cycles of VEGFR2-169 and gemcitabine will be administered until patients develop progressive disease or unacceptable toxicity,or for maximum 2 cycles, whichever occurs first.

Study groups in NCT00622622
Study groupRoleWhat they receive
Phase I studyExperimentalNot described
Receives: Biological: VEGFR2-169 and gemcitabine

What is being measured

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

  1. Safety(toxicities as assessed by NCI CTCAE version 3)

    Measured: 3 months

Secondary outcomes (6)

  1. VEGFR2 peptide specific CTL induction in vitro

    Measured: 3 months

  2. DTH to VEGFR2 peptide

    Measured: 3 months

  3. Changes in levels of regulatory T cells

    Measured: 3 months

  4. Objective response rate as assessed by RECIST criteria

    Measured: 1 year

  5. Time to progression

    Measured: 1 years

  6. survival

    Measured: 1 years

Timeline

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

  1. First posted25 Feb 2008 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2006
  4. Study completionFeb 2009

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00622622
Sponsor's protocol ID
WPR2-0710
Status last verified
Feb 2009
First submitted
13 Feb 2008
Last updated
18 Feb 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • Li Y, Wang MN, Li H, King KD, Bassi R, Sun H, Santiago A, Hooper AT, Bohlen P, Hicklin DJ. Active immunization against the vascular endothelial growth factor receptor flk1 inhibits tumor angiogenesis and metastasis. J Exp Med. 2002 Jun 17;195(12):1575-84. doi: 10.1084/jem.20020072.

    PubMed 12070285

  • 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

  • Date Y, Kimura A, Kato H, Sasazuki T. DNA typing of the HLA-A gene: population study and identification of four new alleles in Japanese. Tissue Antigens. 1996 Feb;47(2):93-101. doi: 10.1111/j.1399-0039.1996.tb02520.x.

    PubMed 8851721

  • Correale P, Cusi MG, Del Vecchio MT, Aquino A, Prete SP, Tsang KY, Micheli L, Nencini C, La Placa M, Montagnani F, Terrosi C, Caraglia M, Formica V, Giorgi G, Bonmassar E, Francini G. Dendritic cell-mediated cross-presentation of antigens derived from colon carcinoma cells exposed to a highly cytotoxic multidrug regimen with gemcitabine, oxaliplatin, 5-fluorouracil, and leucovorin, elicits a powerful human antigen-specific CTL response with antitumor activity in vitro. J Immunol. 2005 Jul 15;175(2):820-8. doi: 10.4049/jimmunol.175.2.820.

    PubMed 16002679

  • Dauer M, Herten J, Bauer C, Renner F, Schad K, Schnurr M, Endres S, Eigler A. Chemosensitization of pancreatic carcinoma cells to enhance T cell-mediated cytotoxicity induced by tumor lysate-pulsed dendritic cells. J Immunother. 2005 Jul-Aug;28(4):332-42. doi: 10.1097/01.cji.0000164038.41104.f5.

    PubMed 16000951

  • Miyazawa M, Ohsawa R, Tsunoda T, Hirono S, Kawai M, Tani M, Nakamura Y, Yamaue H. Phase I clinical trial using peptide vaccine for human vascular endothelial growth factor receptor 2 in combination with gemcitabine for patients with advanced pancreatic cancer. Cancer Sci. 2010 Feb;101(2):433-9. doi: 10.1111/j.1349-7006.2009.01416.x. Epub 2009 Oct 27.

    PubMed 19930156

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VEGFR2-169 and gemcitabine in people with Pancreatic Cancer, run by Wakayama 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 11 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 18 Feb 2009. 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 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.

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?

Safety(toxicities as assessed by NCI CTCAE version 3) (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 NCT00622622, which also lists 7 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 18 Feb 2009.

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Clinical Trial NCT00622622 | AzTrials