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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02007005
Other study ID # AB01
Secondary ID
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


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
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