Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT02007005|
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : May 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Superficial Bladder Cancer||Drug: abnobaVISCUM Fraxini||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose-Escalation-Study With abnobaVISCUM® Fraxini 2 (AVF2) as Intravesical Instillation in Patients With Superficial Bladder Cancer According to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) - Guidelines: a Phase Ib/IIa Study|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||September 2013|
Experimental: Dose escalation
intravesical instillation of abnobaVISCUM Fraxini
Drug: abnobaVISCUM Fraxini
intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs
- Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation [ Time Frame: 6 weeks ]The primary objective is to investigate the maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation in patients with superficial bladder cancer. The treatment schedule included 6 weekly instillations.
- Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation [ Time Frame: 6 weeks ]Secondary objectives are to investigate the local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation. Main variables of safety analysis are adverse events, vital signs and clinical laboratory tests.
- Influence on remission and influence on the one year recurrence rate of abnobaVISCUM Fraxini for intravesical instillation [ Time Frame: up to 1 year ]Secondary objectives are to investigate the influence on remission and influence on the one year recurrence rate measured by histological examination of biopsies of the marker lesion, cytology and cystoscopy.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007005
|Theodor Bilharz Research Institute|
|Giza, Egypt, 12411|
|Clinic of Urology of the University Hospital of Essen|
|Essen, Germany, 45122|
|Study Director:||Herbert Ruebben, Prof.Dr.Dr.||Director of the Urological Clinic of the University Hospital Essen|