Treatment of Recurrent Bladder Cancer With Dendritic Cells

Overview

Treatment of recurrent bladder cancer with dendritic cells

Full Title of Study: “Treatment of Recurrent Bladder Cancer With Autologous Monocyte-derived Dendritic Cells”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Biological: Dendritic cells
    • Autologous dendritic cells primed with muc-1/wt-1 peptides
  • Other: Standard treatment according to the Clinical protocols
    • Standard treatment of bladder cancer according to the Clinical protocols

Arms, Groups and Cohorts

  • Experimental: Dendritic cells
    • Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells
  • Active Comparator: Control
    • Patients with the recurrent bladder cancer receiving standard treatment

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy evaluation
    • Time Frame: 1 year
    • 1 year relapse free survival

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically confirmed diagnosis of pTa bladder cancer;
  • Patient who require repetitive transurethral resection;
  • Expression of muc-1/wt-1 by the tumor;
  • EGOC 0-3;

Exclusion Criteria

  • any medical condition which can be associated with the high risk for the patient;
  • pregnancy/lactation;
  • chronic infections, including hepatitis B/C, tuberculosis, HIV

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
  • Collaborator
    • Belarusian State Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrei Hancharou, Dr, Study Director, Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    • Alexander V Prokharau, Dr, Study Director, Head of the chair, Belarusian State Medical University
  • Overall Contact(s)
    • Andrei Y Hancharou, Dr, +375296248972, andrei.hancharou@gmail.com

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