Back to resultsHuman Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer, Pancreas Neoplasms
Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
VEGFR1-A24-1084 (SYGVLLWEI)
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring cancer, pancreas, advanced, peptide, vaccination, VEGFR1, HLA, gemcitabine, IFA, Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer
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
Sites / Locations
- Research Hospital, The Institute of Medical Science, The University of Tokyo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
Secondary Outcome Measures
Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)
Tumor regression(Imaging study, tumor marker, etc.)
Full Information
NCT ID
NCT00683358
First Posted
May 16, 2008
Last Updated
May 6, 2009
Sponsor
Tokyo University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
1. Study Identification
Unique Protocol Identification Number
NCT00683358
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tokyo University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreas Neoplasms
Keywords
cancer, pancreas, advanced, peptide, vaccination, VEGFR1, HLA, gemcitabine, IFA, Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
VEGFR1-A24-1084 (SYGVLLWEI)
Other Intervention Name(s)
HLA-A*2402, advanced pancreatic cancer, VEGFR1, VEGFR1-A24-1084, SYGVLLWEI, IFA, Montanide ISA51
Intervention Description
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.
Primary Outcome Measure Information:
Title
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)
Time Frame
1 year
Title
Tumor regression(Imaging study, tumor marker, etc.)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naohide Yamashita, MD, PhD
Organizational Affiliation
Director, Research Hospital, Institute of Medical Science, Tokyo University
Official's Role
Study Director
Facility Information:
Facility Name
Research Hospital, The Institute of Medical Science, The University of Tokyo
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8639
Country
Japan
12. IPD Sharing Statement
Citations:
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
14512794
Citation
Nagayama H, Sato K, Morishita M, Uchimaru K, Oyaizu N, Inazawa T, Yamasaki T, Enomoto M, Nakaoka T, Nakamura T, Maekawa T, Yamamoto A, Shimada S, Saida T, Kawakami Y, Asano S, Tani K, Takahashi TA, Yamashita N. Results of a phase I clinical study using autologous tumour lysate-pulsed monocyte-derived mature dendritic cell vaccinations for stage IV malignant melanoma patients combined with low dose interleukin-2. Melanoma Res. 2003 Oct;13(5):521-30. doi: 10.1097/00008390-200310000-00011.
Results Reference
background
Links:
URL
http://www.transrec.jp/english/index.html
Description
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Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
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