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

This study is currently recruiting participants.
Study NCT00683358.   Last updated on May 22, 2008.   Information provided by Tokyo University

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Descriptive Information Fields
Brief Title  Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
Official Title  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
Brief 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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ;time to progression (RECIST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Tumor regression(Imaging study, tumor marker, etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Condition  Pancreatic Cancer
Pancreas Neoplasms
Cancer of Pancreas
Neoplasms, Pancreatic
Pancreas Cancer
Intervention  Biological: VEGFR1-A24-1084 (SYGVLLWEI)
MEDLINE PMIDs 17020992,   14512794
Links Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  14
Start Date  May 2008
Completion Date April 2009
Eligibility Criteria 

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
Gender Both
Ages 20 Years to 85 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Hitomi Nagayama, MD,PhD     81-3-5449-5772 ext 75185     zephyrus@ims.u-tokyo.ac.jp    
Contact: Nagayama            
Location Countries  Japan
Administrative Information Fields
NCT ID  NCT00683358
Organization ID IMSUT-PPKVEGFR12402
Secondary IDs ††
Study Sponsor  Tokyo University
Collaborators †† Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators 
Study Director:     Naohide Yamashita, MD, PhD     Director, Research Hospital, Institute of Medical Science, Tokyo University    
Information Provided By Tokyo University
Verification Date May 2008
First Received Date  May 16, 2008
Last Updated Date May 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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