Text Size

Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Takashi Kimura, Fukushima Medical University
ClinicalTrials.gov Identifier:
NCT00655785
First received: April 4, 2008
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine


Condition Intervention Phase
Pancreatic Cancer
 Biological: VEGFR1-1084, VEGFR2-169
Drug: Gemcitabine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ｉ/Ⅱ Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fukushima Medical University:

Primary Outcome Measures:
  • toxicities as assessed by NCI-CACAE ver3) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration [ Time Frame: 3months ] [ Designated as safety issue: No ]
  • CD8 population [ Time Frame: 3months ] [ Designated as safety issue: No ]
  • Change in level of regulatory T cells [ Time Frame: 3months ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • feasibility [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 1year ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: September 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1/2 study Biological: VEGFR1-1084, VEGFR2-169
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C
Drug: Gemcitabine
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

Detailed Description:

Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

  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

PATIENTS CHARACTERISTICS

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

  3. Laboratory values as follows:

    • 2,000/mm3 < WBC < 15000/mm3
    • Platelet count ≥ 750,000/mm³
    • Total Bilirubin ≤ 1.5 x
    • 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 (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breast-feeder
  3. Active or uncontrolled infection
  4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  5. Serious or uncured wound
  6. Active or uncontrolled other malignancy
  7. Steroids or immunosuppressing agent dependent status
  8. Interstitial pneumonia
  9. Ileus
  10. Decision of unsuitableness by principal investigator or physician-in-charge
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655785

Locations
Japan
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Mitsukazu Gotoh, M.D. & Ph.D Fukushima Medical University, Department
  More Information

Publications:

Responsible Party: Takashi Kimura, Assistant professor, Fukushima Medical University
ClinicalTrials.gov Identifier: NCT00655785     History of Changes
Other Study ID Numbers: FPCR1R2-2
Study First Received: April 4, 2008
Last Updated: March 13, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Fukushima Medical University:
Epitope peptide
CTL
Pancreatic cancer
Vaccination VEGFR1
VEGFR2

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 May 19, 2013