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

Sponsor

Abnoba Gmbh (Industry)

Overall Status

Completed

CT.gov ID

NCT02007005

Collaborator

(none)

Enrollment

Locations

Arm

116

Duration (Months)

18.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2004

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

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

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

Primary Outcome Measures

Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation [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

Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation [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 [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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