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”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

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.

Intervention(s) in this Clinical Trial

• Biological: VEGFR1-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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
  • Time Frame: 1 year
    Safety Issue?: Yes

Secondary Measures

• Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)
  • Time Frame: 1 year
    Safety Issue?: No
• Tumor regression(Imaging study, tumor marker, etc.)
  • Time Frame: 1 year
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Tokyo University

Overall Clinical Trial Officials and Contacts

Naohide Yamashita, MD, PhD Study Director Director, Research Hospital, Institute of Medical Science, Tokyo University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683358

Study ID Number: IMSUT-PPKVEGFR12402

ClinicalTrials.gov Identifier: NCT00683358

Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology