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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Tokyo University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00683358
First received: May 16, 2008
Last updated: May 6, 2009
Last verified: January 2009

May 16, 2008
May 6, 2009
May 2008
April 2009   (final data collection date for primary outcome measure)
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ;time to progression (RECIST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00683358 on ClinicalTrials.gov Archive Site
  • Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Tumor regression(Imaging study, tumor marker, etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
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).

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.

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: 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.
Other Names:
  • HLA-A*2402
  • advanced pancreatic cancer
  • VEGFR1
  • VEGFR1-A24-1084
  • SYGVLLWEI
  • IFA
  • Montanide ISA51
Experimental: 1
Intervention: Biological: VEGFR1-A24-1084 (SYGVLLWEI)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00683358
IMSUT-PPKVEGFR12402
Yes
Naohide Yamashita MD, PhD, Research Hospital, 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
January 2009

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