Status:
UNKNOWN
Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Lead Sponsor:
Patrice Jichlinski
Conditions:
Non Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Bladder cancer is the fourth and eighth most common malignancy among men and women, respectively. About 75% of bladder cancers are diagnosed as non muscle-invasive and according to specific tumor-stag...
Detailed Description
Escalating doses of Ty21a/Vivotif® will be administered by the intravesical route to evaluate whether Ty21 may replace the standard BCG immunotherapy in NMIBC patients. The minimal starting dose will...
Eligibility Criteria
Inclusion
- Patients with an intermediary or low risk of progression of bladder cancer (according to an EORTC score and clinical considerations) and thus not requiring BCG immunotherapy will be included after a transurethral resection of the bladder tumor (TURBT). Male and Female patients aged \> 18yrs, with a Karnofsky performance status of 60% or more, sero-negative for HIV, HBV and HCV and with laboratory parameters for vital function in the normal range or with abnormalities without clinical significance may be included.
Exclusion
- Patients with NMIBC that require BCG treatments or with muscle-invasive bladder cancer, sero-positive for HIV, HBV and HCV or with other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders, autoimmune disease), will be excluded.
Key Trial Info
Start Date :
February 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03421236
Start Date
February 18 2018
End Date
December 1 2022
Last Update
April 28 2021
Active Locations (1)
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1
Dpt Urology- CHUV
Lausanne, Canton of Vaud, Switzerland, 1011