Treatment of Recurrent Bladder Cancer With Dendritic Cells

Phase 2

Completed

• Conditions: Bladder Cancer
• Interventions: Biological: Dendritic cells; Other: Standard treatment according to the Clinical protocols

• Registration Number: NCT04184232
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

Treatment of recurrent bladder cancer with dendritic cells

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-03
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dendritic cells	Dendritic cells	Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells
Control	Standard treatment according to the Clinical protocols	Patients with the recurrent bladder cancer receiving standard treatment
Dendritic cells	Standard treatment according to the Clinical protocols	Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells

Primary Outcome Measures

Name	Time	Method
Efficacy evaluation	1 year	1 year relapse free survival

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus