Spots Global Cancer Trial Database for Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

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Trial Identification

Brief Title: Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Official Title: Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Study ID: NCT01731652

Conditions

Carcinoma in Situ

Non Muscle Invasive Bladder Cancer

Interventions

TMX-101

Study Description

Brief Summary: This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.

Detailed Description: This study is an open label, pilot study of TMX-101 in the treatment of carcinoma in situ. TMX-101 is a new formulation of Imiquimod optimized for intravesical delivery. Imiquimod possesses immune-stimulatory properties. TMX-101 is being developed as a potential treatment for patients with non-invasive bladder cancer, including patients with CIS bladder cancer. Following confirmation of CIS by histology, patients will receive weekly instillations of TMX-101 for 6 weeks. Five to seven weeks after the last instillation, biopsies and cytology will be performed. Response to treatment will be determined based on cytology and tissue sample histology findings.