Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

May 6, 2009 updated by: Tokyo University

Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer

Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.

HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.

These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Minato-ku, Tokyo, Japan, 108-8639
        • Research Hospital, The Institute of Medical Science, The University of Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heterozygote or homozygote of HLA-A*2402 allele
  • Inoperable or recurrent pancreatic cancer with or without any prior therapy
  • Difficult to continue the prior therapy due to treatment-related toxicities
  • ECOG performance status 0-2
  • Evaluable primary or metastatic lesion with RECIST criteria
  • Clearance period from prior therapy more than 4 weeks
  • Life expectancy more than 3 months
  • Laboratory values as follows 2,000/μL<WBC<15,000/μL Platelet count>100,000/μL AST<150IU/L ALT<150IU/L Total bilirubin<3.0mg/dl Serum creatinine<3.0mg/dl

Exclusion Criteria:

  • Pregnancy (refusal or inability to use effective contraceptives)
  • Breastfeeding
  • Active or uncontrolled infection
  • Systemic use of corticosteroids or immunosuppressants
  • Uncontrollable brain metastasis and/or meningeal infiltration
  • Unhealed external wound
  • Possibilities of complicated paralytic ileus or interstitial pneumonitis
  • Decision of not eligible determined by principal investigator or attending doctor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: VEGFR1-A24-1084 (SYGVLLWEI)
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.
Other Names:
  • IFA
  • VEGFR1
  • HLA-A*2402
  • advanced pancreatic cancer
  • VEGFR1-A24-1084
  • SYGVLLWEI
  • Montanide ISA51

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)
Time Frame: 1 year
1 year
Tumor regression(Imaging study, tumor marker, etc.)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo University

Collaborators

Human Genome Center, Institute of Medical Science, University of Tokyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Estimate)

May 7, 2009

Last Update Submitted That Met QC Criteria

May 6, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMSUT-PPKVEGFR12402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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