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

Study Overview
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Brief Summary
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Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells

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

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

Conditions
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Bladder Cancer, Renal Cancer

Intervention / Treatment
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* Biological: cytokine-induced killer cells
* Other: Standard treatment according to the Clinical protocols


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder Cancer, Renal Cancer, CIK