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

May 5, 2015 updated by: Abnoba Gmbh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12411
        • Theodor Bilharz Research Institute
  • Germany
      • Essen, Germany, 45122
        • Clinic of Urology of the University Hospital of Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abnoba Gmbh

Investigators

  • Study Director: Herbert Ruebben, Prof.Dr.Dr., Director of the Urological Clinic of the University Hospital Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Superficial Bladder Cancer

Clinical Trials on abnobaVISCUM Fraxini

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe