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NCT Number: NCT00622622

Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With 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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wakayama Medical University Hospital

811-1 Kimiidera, Wakayama, Wakayama, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

DISEASE CHARACTERISTICS

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

PATIENT CHARACTERISTICS

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • 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
  • HLA-A*2402
  • Able and willing to give valid written informed consent

Exclusion criteria

  • Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Active or uncontrolled infection
  • Concurrent treatment with steroids or immunosuppressing agent
  • Prior chemotherapy of gemcitabine
  • Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  • Serious or nonhealing wound, ulcer, or bone fracture
  • Active or uncontrolled other malignancy
  • Ileus
  • Interstitial pneumonia
  • Decision of unsuitableness by principal investigator or physician-in-charge

Treatment and study plan

VEGFR2-169 and gemcitabine

Biological

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.

Primary outcomes

  1. Safety(toxicities as assessed by NCI CTCAE version 3)

    Time frame: 3 months

Secondary outcomes

  1. VEGFR2 peptide specific CTL induction in vitro

    Time frame: 3 months

  2. DTH to VEGFR2 peptide

    Time frame: 3 months

  3. Changes in levels of regulatory T cells

    Time frame: 3 months

  4. Objective response rate as assessed by RECIST criteria

    Time frame: 1 year

  5. Time to progression

    Time frame: 1 years

  6. survival

    Time frame: 1 years

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Collaborators

  • Human Genome Center, Institute of Medical Science, University of Tokyo

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2009
First posted
Feb 25, 2008
Registry last updated
Feb 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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