NCT00655785

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

5.5 years

First QC Date

April 4, 2008

Last Update Submit

March 13, 2013

Conditions

Pancreatic Cancer

Keywords

Epitope peptideCTLPancreatic cancerVaccination VEGFR1VEGFR2

Outcome Measures

Primary Outcomes (1)

  • toxicities as assessed by NCI-CACAE ver3)

    3 months

Secondary Outcomes (6)

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

    3months

  • CD8 population

    3months

  • Change in level of regulatory T cells

    3months

  • Objective response rate

    1year

  • feasibility

    1year

  • +1 more secondary outcomes

Study Arms (1)

Phase 1/2 study

EXPERIMENTAL
Biological: VEGFR1-1084, VEGFR2-169Drug: Gemcitabine

Interventions

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

Phase 1/2 study
GemcitabineDRUG

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

Phase 1/2 study

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Laboratory values as follows:
  • ,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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Related Publications (3)

  • 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.

    PMID: 12415261BACKGROUND

  • 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.

    PMID: 17020992BACKGROUND

  • 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.

    PMID: 15930316BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mitsukazu Gotoh, M.D. & Ph.D

    Fukushima Medical University, Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

JP(1)