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

Superficial Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007005
• Other study ID #: AB01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 5, 2013
• Last updated: May 5, 2015
• Start date: January 2004
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: Abnoba Gmbh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesEgypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Superficial Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• abnobaVISCUM Fraxini
intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs

Locations

Country	Name	City	State
Egypt	Theodor Bilharz Research Institute	Giza
Germany	Clinic of Urology of the University Hospital of Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Abnoba Gmbh

Countries where clinical trial is conducted

Egypt,  Germany, 

References & Publications (1)

Rose A, El-Leithy T, vom Dorp F, Zakaria A, Eisenhardt A, Tschirdewahn S, Rübben 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation	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	Yes
Secondary	Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation	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	Yes
Secondary	Influence on remission and influence on the one year recurrence rate of abnobaVISCUM Fraxini for intravesical instillation	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	No