This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Fukushima Medical University.
Recruitment status was:  Active, not recruiting
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Fukushima Medical University Identifier:
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.

Condition Intervention Phase
Pancreatic Cancer Biological: VEGFR1, VEGFR2 Drug: Gemcitabine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide 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:

Further study details as provided by Fukushima Medical University:

Primary Outcome Measures:
  • Toxicities as assessed by NCI-CACAE ver3 [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration [ Time Frame: 3 months ]
  • CD8 population [ Time Frame: 3 months ]
  • Change in level of regulatory T cells [ Time Frame: 3 months ]
  • Objective response rate [ Time Frame: 1 year ]
  • Feasibility [ Time Frame: 1 year ]
  • Survival [ Time Frame: 1 year ]

Enrollment: 6
Study Start Date: April 2008
Estimated Study Completion Date: March 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 study


Biological: VEGFR1, VEGFR2 Drug: Gemcitabine

Biological: VEGFR1, VEGFR2
One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22
Other Name: VEGFR1 and VEGFR2 specific epitope vaccine
Drug: Gemcitabine
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.
Other Name: Gemzar

Detailed Description:
The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  • Measurable disease by CT scan
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • laboratory values as follows: 2,000/mm3 < WBC < 15,000/mm3, Platelet count >75,000/mm3, Total Bilirubin <1.5 mg/dl, Asparate transaminase <150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
  • HLA-A*0201
  • Able and willing to give valid written infromed consent

Exclusion Criteria:

  • Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  • Breast-feeder
  • Active or uncontrolled infection
  • Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  • Serious or uncured wound
  • Active or uncontrolled other malignancy
  • Steroids or immunosuppressing agent dependent status
  • Interstitial pneumonia
  • Ileus
  • 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 identifier: NCT01266720

Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Mitsukazu Gotoh, MD & PhD Fukushima Medical University, Department of Regeneration Surgery
  More Information

Responsible Party: Fukushima Medical University (Department of Regeneration Surgery), Fukushima Medical University Identifier: NCT01266720     History of Changes
Other Study ID Numbers: 689
Study First Received: December 23, 2010
Last Updated: December 23, 2010

Keywords provided by Fukushima Medical University:
pancreatic cancer
peptide vaccine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents processed this record on August 16, 2017