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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Superficial Bladder Cancer Drug: abnobaVISCUM Fraxini Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • viscum album extract
  • mistletoe extract
  • abnobaVISCUM


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007005


Locations
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Egypt
Theodor Bilharz Research Institute
Giza, Egypt, 12411
Germany
Clinic of Urology of the University Hospital of Essen
Essen, Germany, 45122
Sponsors and Collaborators
Abnoba Gmbh
Investigators
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Study Director: Herbert Ruebben, Prof.Dr.Dr. Director of the Urological Clinic of the University Hospital Essen
More Information
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Publications of Results:

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Responsible Party: Abnoba Gmbh
ClinicalTrials.gov Identifier: NCT02007005    
Other Study ID Numbers: AB01
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by Abnoba Gmbh:
superficial bladder cancer
mistletoe extract
maximum tolerated dose
 marker tumor
remission
recurrence rate
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
 Urologic Diseases
Male Urogenital Diseases
Viscum album peptide
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents