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
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Biological: VEGFR2-169 and gemcitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Safety(toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: November 2006
Study Completion Date: February 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I study 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00622622

Locations
Japan
Wakayama Medical University Hospital
811-1 Kimiidera, Wakayama, Wakayama, Japan
Sponsors and Collaborators
Wakayama Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Hiroki Yamaue, MD Wakayama Medical University, Second Department of Surgery
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00622622     History of Changes
Other Study ID Numbers: WPR2-0710
Study First Received: February 13, 2008
Last Updated: February 17, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on August 21, 2014