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Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

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

NCT00683358•Tokyo University

View on ClinicalTrials.gov

Summary

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).

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.

Eligibility

Age

20 - 85 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Research Hospital, The Institute of Medical Science, The University of Tokyo

Minato-ku, Tokyo, Japan

Key Dates

Start Date

May 1, 2008

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

May 7, 2009

Enrollment

ESTIMATED participants

Conditions

Pancreatic CancerPancreas Neoplasms

Interventions

VEGFR1-A24-1084 (SYGVLLWEI)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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