Treatment of Recurrent Bladder Cancer With Dendritic Cells

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184232
• Other study ID #: IBCE_DC1(BLAD)
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment of recurrent bladder cancer with dendritic cells

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belarus	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy evaluation	1 year relapse free survival	1 year