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Trial record 70 of 2867 for:    Pancreatic Cancer AND pancreas

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

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ClinicalTrials.gov Identifier: NCT00683085
Recruitment Status : Terminated (Lack of eligible patient)
First Posted : May 23, 2008
Results First Posted : December 17, 2010
Last Update Posted : July 22, 2011
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Cancer
Pancreas Neoplasms
Intervention Biological: HLA-A*02:01-restricted VEGFR1-derived peptide vaccination
Enrollment 2
Recruitment Details Neighboring research hospitals around Tokyo, Japan sent three candidates to our hospital during May, 2008 to March, 2009.
Pre-assignment Details 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.
Arm/Group Title Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Hide Arm/Group Description 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
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Hide Arm/Group Description 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
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
55  (7.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
1.Primary Outcome
Title Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events
Hide Description Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Number of Participants With Tumor Regression
Hide Description Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
intension to treat (ITT)
Arm/Group Title Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
Time Frame During 2 months after initiation of vaccination
Adverse Event Reporting Description Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events
 
Arm/Group Title Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Hide Arm/Group Description 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
All-Cause Mortality
Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Gastrointestinal disorders   
Blood in stool * 1  1/2 (50.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, ICD9CM_2007
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  1/2 (50.00%)  1
Leukocytes  1  2/2 (100.00%)  2
Lymphopenia  1  1/2 (50.00%)  1
Neutrophils  1  2/2 (100.00%)  2
Platelets  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Injection site reaction * 1  2/2 (100.00%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTCAE v.3.0
Early termination leading to small numbers of subjects analyzed
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.
Results Point of Contact
Layout table for Results Point of Contact information
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
EMail: zephyrus@ims.u-tokyo.ac.jp
Layout table for additonal information
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
First Submitted: May 16, 2008
First Posted: May 23, 2008
Results First Submitted: June 9, 2009
Results First Posted: December 17, 2010
Last Update Posted: July 22, 2011