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

January 12, 2022 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belarus
      • Minsk, Belarus, 220072
        • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cytokine-induced killer cells
Patients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells
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
Active Comparator: Control
Patients with metastatic tumors of the urogenital area receiving standard treatment
Other: Standard treatment according to the Clinical protocols
Standard treatment of bladder/renal cancer according to the Clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects associated with the therapy
Time Frame: 1 month
Determination of adverse effects associated with the therapy
1 month
Adverse effects associated with the therapy
Time Frame: 1 year
Determination of adverse effects associated with the therapy
1 year
The relapse-free survival
Time Frame: 1 year
The duration of relapse-free survival
1 year
The relapse-free survival
Time Frame: 2 year
The duration of relapse-free survival
2 year
The relapse-free survival
Time Frame: 3 year
The duration of relapse-free survival
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Belarusian State Medical University

Investigators

  • Study Director: Andrei Hancharou, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
  • Study Director: Alexander Prokhorov, Dr, Belarusian State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_CIK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bladder Cancer

Clinical Trials on cytokine-induced killer cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe