Treatment of Recurrent Bladder Cancer With Dendritic Cells

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

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer

Treatments: Other: Standard treatment according to the Clinical protocols; Biological: Dendritic cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04184232

IBCE_DC1(BLAD)

Details and patient eligibility

About

Treatment of recurrent bladder cancer with dendritic cells

Enrollment: 17 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Dendritic cells

Experimental group

Description:

Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells

Treatment:

Other: Standard treatment according to the Clinical protocols

Biological: Dendritic cells

Control

Active Comparator group

Description:

Patients with the recurrent bladder cancer receiving standard treatment

Treatment:

Other: Standard treatment according to the Clinical protocols