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Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00622622
First received: February 13, 2008
Last updated: February 17, 2009
Last verified: February 2009
History of Changes

February 13, 2008
February 17, 2009
November 2006
December 2006   (final data collection date for primary outcome measure)
Safety(toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00622622 on ClinicalTrials.gov Archive Site
  • VEGFR2 peptide specific CTL induction in vitro [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • DTH to VEGFR2 peptide [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in levels of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Objective response rate as assessed by RECIST criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 1 years ] [ Designated as safety issue: No ]
  • survival [ Time Frame: 1 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer
Phase I Study of Gemcitabine With Antiangiogenic Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 Derived From VEGFR2 in Patients With Unresectable, Locally Advanced, Recurrent or Metastatic Pancreatic Cancer
The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.
Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Biological: VEGFR2-169 and gemcitabine
Escalating doses of VEGFR2-169 will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles(doses of 0.5,1.0,2.0mg/body are planned). Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days 1,8 and 15. Repeated cycles of VEGFR2-169 and gemcitabine will be administered until patients develop progressive disease or unacceptable toxicity,or for maximum 2 cycles, whichever occurs first.
Experimental: Phase I study
Intervention: Biological: VEGFR2-169 and gemcitabine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
February 2009
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

DISEASE CHARACTERISTICS

  1. locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  2. measurable disease by CT scan

PATIENT CHARACTERISTICS

  1. ECOG performance status 0-2
  2. Life expectancy > 3 months

  3. Laboratory values as follows

    • 2000/mm3 < WBC < 15000/mm3
    • Platelet count > 75000/mm3
    • Bilirubin < 3.0 mg/dl
    • Aspartate transaminase < 150 IU/L
    • Alanine transaminase < 150 IU/L
    • Creatinine < 3.0 mg/dl
  4. HLA-A*2402
  5. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Active or uncontrolled infection
  4. Concurrent treatment with steroids or immunosuppressing agent
  5. Prior chemotherapy of gemcitabine
  6. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  7. Serious or nonhealing wound, ulcer, or bone fracture
  8. Active or uncontrolled other malignancy
  9. Ileus
  10. Interstitial pneumonia
  11. Decision of unsuitableness by principal investigator or physician-in-charge
Both
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00622622
WPR2-0710
Yes
Not Provided
Not Provided
Second Department of Surgery, Wakayama Medical University
Wakayama Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Hiroki Yamaue, MD Wakayama Medical University, Second Department of Surgery
Wakayama Medical University
February 2009

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