Treatment of Recurrent Bladder Cancer With Dendritic Cells

January 20, 2021 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Treatment of Recurrent Bladder Cancer With Autologous Monocyte-derived Dendritic Cells

Treatment of recurrent bladder cancer with dendritic cells

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220072
        • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dendritic cells
Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells
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
Active Comparator: Control
Patients with the recurrent bladder cancer receiving standard treatment
Other: Standard treatment according to the Clinical protocols
Standard treatment of bladder cancer according to the Clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy evaluation
Time Frame: 1 year
1 year relapse free survival
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Collaborators

Belarusian State Medical University

Investigators

  • Study Director: Alexander V Prokharau, Dr, Head of the chair, Belarusian State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 1, 2019

First Submitted That Met QC Criteria

December 1, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_DC1(BLAD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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