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
20 Years
85 Years
Both
Pancreatic Cancer, Pancreas Neoplasms
Trial Information
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
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.
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Naohide Yamashita, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Director, Research Hospital, Institute of Medical Science, Tokyo University
Authority:
Japan: Ministry of Education, Culture, Sports, Science and Technology
Study ID:
IMSUT-PPKVEGFR12402
NCT ID:
NCT00683358
Start Date:
May 2008
Completion Date:
April 2009
Related Keywords:
- Pancreatic Cancer
- Pancreas Neoplasms
- cancer
- pancreas
- advanced
- peptide
- vaccination
- VEGFR1
- HLA
- gemcitabine
- IFA
- Cancer of Pancreas
- Neoplasms, Pancreatic
- Pancreas Cancer
- Neoplasms
- Pancreatic Neoplasms
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