Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Phase 1

• Conditions: Pancreatic Cancer; Pancreas Neoplasms

• Registration Number: NCT00683358
• Lead Sponsor: Tokyo University

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Status Verified: 2009-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-05-06
• Last Update Posted: 2009-05-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)	1 year

Secondary Outcome Measures

Name	Time	Method
Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)	1 year
Tumor regression(Imaging study, tumor marker, etc.)	1 year

Trial Locations

Locations (1)

Research Hospital, The Institute of Medical Science, The University of Tokyo; 🇯🇵 Minato-ku, Tokyo, Japan