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

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ClinicalTrials.gov Identifier: NCT01266720
Recruitment Status : Unknown
Verified December 2010 by Fukushima Medical University.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : December 24, 2010
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Fukushima Medical University

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Biological: VEGFR1, VEGFR2 Drug: Gemcitabine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : March 2010
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1 study

Interventions:

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




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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266720


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, MD & PhD Fukushima Medical University, Department of Regeneration Surgery

Publications:
Responsible Party: Fukushima Medical University (Department of Regeneration Surgery), Fukushima Medical University
ClinicalTrials.gov Identifier: NCT01266720     History of Changes
Other Study ID Numbers: 689
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: December 24, 2010
Last Verified: December 2010

Keywords provided by Fukushima Medical University:
pancreatic cancer
peptide vaccine
VEGFR
gemcitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Vaccines
Gemcitabine
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents