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Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02007005
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Abnoba Gmbh

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 10, 2013
Last Update Posted Date May 6, 2015
Study Start Date  ICMJE January 2004
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
Official Title  ICMJE 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
Brief Summary The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.
Detailed Description A dose-escalation-study according ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) with different concentrations of abnobaVISCUM® Fraxini is conducted in two hospitals in Germany and Egypt. Patients with superficial bladder cancer TaG1/G2 or T1G1/G2 are enclosed after TUR-B (transurethral resection bladder). The tolerability of the different concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. A direct antitumoral effect is assessed on a single marker tumor left in the bladder after a complete TUR of all other lesions according a study design established by the EORTC-GENITO-URINARY GROUP (European Organisation for Research and Treatment of Cancer). A re-TUR is conducted after 12 weeks. Tumor response is measured by biopsy of the marker lesion and by cytology. Safety of the instillations is measured by analysis of adverse events, vital signs and clinical laboratory tests. After treatment of a cohort is finished a safety evaluation is conducted to decide about the increase to the next dosage.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Superficial Bladder Cancer
Intervention  ICMJE Drug: abnobaVISCUM Fraxini
intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs
Other Names:
  • viscum album extract
  • mistletoe extract
  • abnobaVISCUM
Study Arms  ICMJE Experimental: Dose escalation
intravesical instillation of abnobaVISCUM Fraxini
Intervention: Drug: abnobaVISCUM Fraxini
Publications * Rose A, El-Leithy T, vom Dorp F, Zakaria A, Eisenhardt A, Tschirdewahn S, Rubben H. Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study. J Urol. 2015 Oct;194(4):939-43. doi: 10.1016/j.juro.2015.04.073. Epub 2015 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2013)		 37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection
  • Written informed consent for study participation and for documentation of disease data including further distribution of these data

Exclusion Criteria:

  • Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS)
  • Intravesical instillation therapy within 6 months prior to study enrolment
  • Radiotherapy of the bladder prior to study enrolment
  • Contracted bladder (capacity less than 100 ml)
  • Non treated acute or chronic urinary tract infection
  • Allergy against mistletoe extract preparations
  • Subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml)
  • Severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse)
  • Pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception
  • Participation in another clinical study within 30 days prior to this study
  • Administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment
  • Chronic progressive infections (e. g. tuberculosis)
  • Pre-treatment with mistletoe extracts/mistletoe lectins
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02007005
Other Study ID Numbers  ICMJE AB01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Abnoba Gmbh
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abnoba Gmbh
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Herbert Ruebben, Prof.Dr.Dr. Director of the Urological Clinic of the University Hospital Essen
PRS Account Abnoba Gmbh
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP