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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fukushima Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Fukushima Medical University
ClinicalTrials.gov Identifier:
NCT01266720
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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: Endpoint Classification: Safety Study
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 ] [ 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: 3 months ] [ Designated as safety issue: No ]
  • CD8 population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in level of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

Additional Information:
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
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: Japan: Institutional Review Board

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
Gemcitabine
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

ClinicalTrials.gov processed this record on October 02, 2014