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

Primary Purpose

Bladder Cancer, Renal Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
cytokine-induced killer cells
Standard treatment according to the Clinical protocols
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder Cancer, Renal Cancer, CIK

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cytokine-induced killer cells

Control

Arm Description

Patients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells

Patients with metastatic tumors of the urogenital area receiving standard treatment

Outcomes

Primary Outcome Measures

The relapse-free survival
The duration of relapse-free survival
The relapse-free survival
The duration of relapse-free survival
The relapse-free survival
The duration of relapse-free survival
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
January 12, 2022
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05108077
Brief Title
Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells
Official Title
Treatment of Metastatic Tumors of the Urogenital Area (Bladder Cancer, Renal Cancel) With Cytokine-induced Killer Cells
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells
Detailed Description
Treatment of metastatic tumors of the urogenital area using autologous cytokine-induced killer cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Renal Cancer
Keywords
Bladder Cancer, Renal Cancer, CIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cytokine-induced killer cells
Arm Type
Experimental
Arm Description
Patients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients with metastatic tumors of the urogenital area receiving standard treatment
Intervention Type
Biological
Intervention Name(s)
cytokine-induced killer cells
Intervention Description
Autologous cytokine-induced killer cells injected intravenously
Intervention Type
Other
Intervention Name(s)
Standard treatment according to the Clinical protocols
Intervention Description
Standard treatment of bladder/renal cancer according to the Clinical protocols
Primary Outcome Measure Information:
Title
The relapse-free survival
Description
The duration of relapse-free survival
Time Frame
1 year
Title
The relapse-free survival
Description
The duration of relapse-free survival
Time Frame
2 year
Title
The relapse-free survival
Description
The duration of relapse-free survival
Time Frame
3 year
Title
Adverse effects associated with the therapy
Description
Determination of adverse effects associated with the therapy
Time Frame
1 month
Title
Adverse effects associated with the therapy
Description
Determination of adverse effects associated with the therapy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrei Hancharou, Dr
Phone
+375296248972
Email
hancharou@ibp.org.by
First Name & Middle Initial & Last Name or Official Title & Degree
Oksana Timohina
Phone
+375299649741
Email
oksanabuschik@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Hancharou
Organizational Affiliation
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexander Prokhorov, Dr
Organizational Affiliation
Belarusian State Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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