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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
  Purpose

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).


Condition Intervention Phase
Pancreatic Cancer
Pancreas Neoplasms
Biological: VEGFR1-A24-1084 (SYGVLLWEI)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tokyo University:

Primary Outcome Measures:
  • PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ;time to progression (RECIST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 14
Study Start Date: May 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683358

Locations
Japan
Research Hospital, The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, Japan, 108-8639
Sponsors and Collaborators
Tokyo University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Director: Naohide Yamashita, MD, PhD Director, Research Hospital, Institute of Medical Science, Tokyo University
  More Information

Additional Information:
Publications:
Responsible Party: Naohide Yamashita MD, PhD, Research Hospital, Institute of Medical Science, The University of Tokyo
ClinicalTrials.gov Identifier: NCT00683358     History of Changes
Other Study ID Numbers: IMSUT-PPKVEGFR12402
Study First Received: May 16, 2008
Last Updated: May 6, 2009
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Tokyo University:
cancer
pancreas
advanced
peptide
vaccination
VEGFR1
HLA
gemcitabine
IFA
Cancer of Pancreas
Neoplasms, Pancreatic
Pancreas Cancer

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014