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Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

This study has been terminated.
(Lack of eligible patient)
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00683085
First received: May 16, 2008
Last updated: July 20, 2011
Last verified: July 2011

May 16, 2008
July 20, 2011
May 2008
May 2009   (final data collection date for primary outcome measure)
Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)
Phase 1; safety (NCI CTCAE v.3) Phase 2; time to progression (RECIST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00683085 on ClinicalTrials.gov Archive Site
Number of Participants With Tumor Regression [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.
  • Immune response (ELISPOT, FACS for perforin/FOXP3, in vitro CTL assay, etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Tumor regression (RECIST by imaging study, tumor marker, etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
Phase I/II Trial of Human Leukocyte Antigen (HLA)-A*02:01-restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Conventional Dose of Gemcitabine for Advanced Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the United States, and no combination therapy is far superior to gemcitabine alone. Vascular endothelial growth factor receptor type 1 (VEGFR1) is expressed on the tumor vessels and a candidate of tumor vessel-specific peptide vaccination strategy to induce T cell immune response. We conducted the study to confirm the safety and efficacy of combined modality intervention using conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific VEGFR1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000 mg/m^2 (body surface area) will be administered on day 1, day 8, day 15, day 29, day 36, and day 43, respectively.

VEGFR1-derived HLA-A*02:01-restricted peptide (VEGFR1-A02-770; TLFWLLLTL) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).

HLA-A*02:01-restricted VEGFR1-specific cytotoxic T lymphocyte (CTL) responses were obtained from HLA-A2/Kd transgenic murine model.

HLA-A*02:01-restricted VEGFR1-specific CTL clones were also obtained from peripheral blood mononuclear cells of healthy volunteer donors.

These CTL clones showed potent anti-tumor CTL responses in HLA class Ⅰ-restricted manner in vitro.

Vaccination of HLA-A*02:01-restricted VEGFR1-specific peptide to A2/Kd transgenic mice markedly suppress the tumor-induced angiogenesis and tumor growth in vivo.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Pancreas Neoplasms
Biological: HLA-A*02:01-restricted VEGFR1-derived peptide vaccination
VEGFR1-derived HLA-A*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the feasibility and efficacy of this type of peptide.
Other Name: VEGFR1-A2-770; TLFWLLLTL
Experimental: Peptide vaccination
VEGFR1-derived HLA-A*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the safety and efficacy of this type of peptide.
Intervention: Biological: HLA-A*02:01-restricted VEGFR1-derived peptide vaccination

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Heterozygote or homozygote of HLA-A*02:01 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 v.1.0 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 <150 IU/L ALT <150 IU/L Total bilirubin <3.0 mg/dl Serum creatinine <3.0 mg/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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00683085
IMSUT-PPKVEGFR10201
Yes
Naohide Yamashita MD,PhD, Research Hospital, The Institute of Medical Science, The University of Tokyo
Tokyo University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Director: Naohide Yamashita, MD, PhD Director, Research Hospital, Institute of Medical Science, Tokyo University
Tokyo University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP