Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells

Bladder Cancer Clinical Trial

Official title:

Treatment of Metastatic Tumors of the Urogenital Area (Bladder Cancer, Renal Cancel) With Cytokine-induced Killer Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05108077
• Other study ID #: IBCE_CIK
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: Andrei Hancharou, Dr
• Phone: +375296248972
• Email: hancharou[@]ibp.org.by
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells

Description:

Treatment of metastatic tumors of the urogenital area using autologous cytokine-induced killer cells

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of pTa metastatic tumors of the urogenital area;
• 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
• Carcinoma, Renal Cell
• Kidney Neoplasms
• Neoplasm Metastasis
• Renal Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• cytokine-induced killer cells
Autologous cytokine-induced killer cells injected intravenously

Other:
• Standard treatment according to the Clinical protocols
Standard treatment of bladder/renal 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	The relapse-free survival	The duration of relapse-free survival	1 year
Primary	The relapse-free survival	The duration of relapse-free survival	2 year
Primary	The relapse-free survival	The duration of relapse-free survival	3 year
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 month
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 year