Pancreas Neoplasms, Pancreatic Cancer
Conditions
Keywords
cancer, pancreas, advanced, peptide, vaccination, VEGFR1, HLA, gemcitabine, IFA, Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer
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.
Interventions
BIOLOGICALVEGFR1-A24-1084 (SYGVLLWEI)
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.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Tokyo University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.) | 1 year |
| Tumor regression(Imaging study, tumor marker, etc.) | 1 year |
Countries
Japan
Outcome results
None listed