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Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

This study has been terminated.
(Lack of eligible patient)
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00683085
First received: May 16, 2008
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
Results First Received: June 9, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pancreatic Cancer
Pancreas Neoplasms
Intervention: Biological: HLA-A*02:01-restricted VEGFR1-derived peptide vaccination

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Neighboring research hospitals around Tokyo, Japan sent three candidates to our hospital during May, 2008 to March, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Wash out time was four weeks from preceding therapy, and three candidates were evaluated for eligibility. Two cases were compatible to our eligibility, but another candidate was excluded from this study entry because he was not expected to survive more than three months.

Reporting Groups
  Description
Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area

Participant Flow:   Overall Study
    Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area

Baseline Measures
    Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine  
Number of Participants  
[units: participants]
 		  2  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  55  ± 7.07  
Gender  
[units: participants]
 		 
Female     0  
Male     2  



  Outcome Measures
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1.  Primary:   Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events   [ Time Frame: 2 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Tumor Regression   [ Time Frame: 2 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed  


Results Point of Contact:  
Name/Title: Hitomi Nagayama, M.D., Ph.D. / Project Lecturer
Organization: Research Hospital, The Institute of Medical Science, The University of Tokyo
phone: +81-3-3443-8111
e-mail: zephyrus@ims.u-tokyo.ac.jp


Publications:


Responsible Party: Naohide Yamashita MD,PhD, Research Hospital, The Institute of Medical Science, The University of Tokyo
ClinicalTrials.gov Identifier: NCT00683085     History of Changes
Other Study ID Numbers: IMSUT-PPKVEGFR10201
Study First Received: May 16, 2008
Results First Received: June 9, 2009
Last Updated: July 20, 2011
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology