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

Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05108077
Collaborator
Belarusian State Medical University (Other)
20
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: cytokine-induced killer cells
  • Other: Standard treatment according to the Clinical protocols
 Phase 1/Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Metastatic Tumors of the Urogenital Area (Bladder Cancer, Renal Cancel) With Cytokine-induced Killer Cells
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The relapse-free survival [1 year]

    The duration of relapse-free survival

  2. The relapse-free survival [2 year]

    The duration of relapse-free survival

  3. The relapse-free survival [3 year]

    The duration of relapse-free survival

  4. Adverse effects associated with the therapy [1 month]

    Determination of adverse effects associated with the therapy

  5. Adverse effects associated with the therapy [1 year]

    Determination of adverse effects associated with the therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk Belarus 220072

Sponsors and Collaborators

  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
ClinicalTrials.gov Identifier:
NCT05108077
Other Study ID Numbers:
  • IBCE_CIK
First Posted:
Nov 4, 2021
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Bladder Cancer
Renal Cancer
CIK
Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasm Metastasis

Study Results

No Results Posted as of Jan 14, 2022