Back to resultsAntiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
VEGFR1-1084, VEGFR2-169
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Epitope peptide, CTL, Pancreatic cancer, Vaccination VEGFR1, VEGFR2
Eligibility Criteria
Inclusion Criteria:
DISEASE CHARACTERISTICS
- Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
- Measurable disease by CT scan
PATIENTS CHARACTERISTICS
- ECOG performance status 0-2
- Life expectancy > 3 months
Laboratory values as follows:
- 2,000/mm3 < WBC < 15000/mm3
- Platelet count ≥ 750,000/mm³
- Total Bilirubin ≤ 1.5 x
- Aspartate transaminase < 150 IU/L
- Alanine transaminase < 150 IU/L
- Creatinine ≤ 3.0 mg/dl
- HLA-A*2402
- Able and willing to give valid written informed consent
Exclusion Criteria:
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breast-feeder
- Active or uncontrolled infection
- Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
- Serious or uncured wound
- Active or uncontrolled other malignancy
- Steroids or immunosuppressing agent dependent status
- Interstitial pneumonia
- Ileus
- Decision of unsuitableness by principal investigator or physician-in-charge
Sites / Locations
- Fukushima Medical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phase 1/2 study
Arm Description
Outcomes
Primary Outcome Measures
toxicities as assessed by NCI-CACAE ver3)
Secondary Outcome Measures
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
CD8 population
Change in level of regulatory T cells
Objective response rate
feasibility
Survival
Full Information
NCT ID
NCT00655785
First Posted
April 4, 2008
Last Updated
March 13, 2013
Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
1. Study Identification
Unique Protocol Identification Number
NCT00655785
Brief Title
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)
Official Title
Phase Ｉ/Ⅱ Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine
Detailed Description
Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Epitope peptide, CTL, Pancreatic cancer, Vaccination VEGFR1, VEGFR2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1/2 study
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
VEGFR1-1084, VEGFR2-169
Intervention Description
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17
Primary Outcome Measure Information:
Title
toxicities as assessed by NCI-CACAE ver3)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
Time Frame
3months
Title
CD8 population
Time Frame
3months
Title
Change in level of regulatory T cells
Time Frame
3months
Title
Objective response rate
Time Frame
1year
Title
feasibility
Time Frame
1year
Title
Survival
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DISEASE CHARACTERISTICS
Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
Measurable disease by CT scan
PATIENTS CHARACTERISTICS
ECOG performance status 0-2
Life expectancy > 3 months
Laboratory values as follows:
2,000/mm3 < WBC < 15000/mm3
Platelet count ≥ 750,000/mm³
Total Bilirubin ≤ 1.5 x
Aspartate transaminase < 150 IU/L
Alanine transaminase < 150 IU/L
Creatinine ≤ 3.0 mg/dl
HLA-A*2402
Able and willing to give valid written informed consent
Exclusion Criteria:
Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Breast-feeder
Active or uncontrolled infection
Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
Serious or uncured wound
Active or uncontrolled other malignancy
Steroids or immunosuppressing agent dependent status
Interstitial pneumonia
Ileus
Decision of unsuitableness by principal investigator or physician-in-charge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsukazu Gotoh, M.D. & Ph.D
Organizational Affiliation
Fukushima Medical University, Department
Official's Role
Study Chair
Facility Information:
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
12415261
Citation
Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.
Results Reference
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PubMed Identifier
17020992
Citation
Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
Results Reference
background
PubMed Identifier
15930316
Citation
Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
Results Reference
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Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)
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