Therapeutic Instillation of Mistletoe
Conditions
Superficial Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
superficial bladder cancer, viscum album extract, mistletoe extract, abnobaVISCUM, recurrence rate
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: abnobaVISCUM 900 Type: Drug
Name: Mitomycin C Type: Drug
Overall Status
Recruiting
Summary
The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, the tumor grading in case of a recurrence and by measurement of Quality of Life.
Detailed Description
This is a randomized, open-label, active-controlled, prospective, multinational Phase III confirmative study with 2 treatment groups and an adaptive design (Bauer and Köhne, 1994). The study is designed to compare the efficacy of treatment with abnobaVISCUM® 900 with Mitomycin C (MMC). Patients with completely resected superficial bladder carcinoma (Stage Ta) with an intermediate risk classification according to the European Association of Urology (EAU, update 2013) and with one immediately post operative MMC 40 mg intravesical instillation will be eligible for inclusion in the study.

The study comprises a screening period of not more than 4 weeks, a treatment period of 12 months for abnobaVISCUM® 900 and MMC and a follow-up period of 12 months. Patients will be screened within 4 weeks after the transurethral resection of the bladder (TURB) and the immediately post operative MMC 40 mg intravesical instillation. A re-resection should be performed before inclusion if indicated. Every patient is to provide written informed consent before any study related procedures will be performed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Signed and dated written informed consent for data protection and willingness to participate and comply with the study protocol prior to any study-related procedures

- Completely resected (detrusor muscle in the TUR specimen has to be present) superficial bladder carcinoma (Stage Ta) with classification as intermediate-risk according to the EAU (update 2013) and one immediately post operative intravesical MMC instillation of 40 mg, completed re-resection if indicated

- Karnofsky Performance Status of 50% to 100% (corresponding to Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2)

- Life expectancy of ≥ 2 years at the time point of study inclusion

- Normal renal and liver function, normal cardiac and hematology profiles (patients with laboratory values slightly outside the reference range may be included, unless the investigator considers the abnormality as clinically significant)

- Female patients of childbearing potential must have a negative pregnancy test (β-human chorionic gonadotropin test) at Screening. Pregnancy during the treatment period including 12 weeks after the last instillation has to be excluded

Exclusion Criteria:

- Locally infiltrative or metastatic bladder tumor (Stage T2 or greater), low-risk Ta tumor (primary, solitary, LG/G1, <3 cm, no CIS) or high-risk tumors according to EAU classification, update 2013 (T1; HG/G3; CIS; multiple and recurrent and large [>3 cm] Ta G1/G2 tumors [all conditions must be present at this point], presence of upper urinary tract tumors or lesions which were not completely removed by TURB

- Urinary tract infection, benign prostatic obstruction grade II or III, neurogenic bladder, stress incontinence, bladder or urethral diverticula, fistulas or urethral stenosis

- Patients with acute systemic illness, such as inflammatory infections with fever > 38°C

- Patients with previous recurrence of a superficial bladder cancer or radiotherapy of the bladder or other intravesical treatment within the last 6 months, or patients with previous mistletoe therapy

- Patients with other previous or co-existing malignancies or CIS

- Patients having any previous or concurrent therapy with a systemic chemo- / immunotherapeutical treatment regimen, in particular vinca alkaloids, bleomycine and doxorubicine, or patients who are treated with pyroxidine hydrochloride (vitamin B6)

- Untreated coagulation disorders or inadequate anticoagulation therapy

- Leukocyte count < 4,000/mm3 or platelet count < 100,000/mm3

- Serum creatinine > 1.7 mg/dL

- Patients with known hypersensitivity to the excipients of the study medication (monosodium phosphate, disodium phosphate, ascorbic acid)

- Patients with a known hypersensitivity to mistletoe products and MMC

- Patients who were administered within a 4-week period before Visit 1 any other experimental drug under investigation

- Male patients planning to father a child or sperm donation from the first administration of study medication until 3 months after the last administration of the study medication

- Male patients unwilling to use barrier contraception ie, condoms and spermicide, from the day of first administration of the study medication until 12 weeks after administration of the study medication

- Patients with a history of alcohol and / or drug abuse

- Patients who are unable to be regularly observed, not permitting adequate follow-up and compliance to the protocol
Locations
Theodor Bilharz Research Institute
Giza, Egypt
Status: Not yet recruiting
Contact: Tarek El Leithy, Prof. Dr. - +2 01222117206
Urologische Gemeinschaftspraxis
Berlin-Wilmersdorf, Germany
Status: Recruiting
Contact: Jörg Schröder, Dr. - +49 30 88663500
Klinikum am Urban Klinik für Urologie
Berlin, Germany
Status: Recruiting
Contact: Dimitrios Manos, Dr. - +49 30 130226362
Urologische Gemeinschaftspraxis
Berlin, Germany
Status: Not yet recruiting
Contact: Roger Zillmann, Dipl.-Med. - +49 30 4853868
Urologische Praxis
Berlin, Germany
Status: Not yet recruiting
Contact: Frank Christoph, PD Dr. - +49 30 8915025
Urologische Praxis Bonn-Rhein-Sieg
Bonn, Germany
Status: Recruiting
Contact: Reinhold Schaefer, Dr. - +49 228 957370
Urologisches Praxiszentrum UPZ
Darmstadt, Germany
Status: Recruiting
Contact: Haiko Machemer, Dr. - +49 6151 420270
Urologicum Duisburg
Duisburg, Germany
Status: Recruiting
Contact: Andreas Swoboda, Dr. - +49 203 50030420
Überörtliche urologische Gemeinschaftspraxis
Erkrath, Germany
Status: Recruiting
Contact: Wolfgang Rulf, Dr. - +49 2104 43048
Clinic of Urology of the University Hospital of Essen
Essen, Germany
Status: Recruiting
Contact: Herbert Ruebben, Prof.Dr.Dr. - +49 201 7233211
Urologische Gemeinschaftspraxis
Göttingen, Germany
Status: Not yet recruiting
Contact: Marc Bode, Dr. - +49 551 4950413
Urologikum Hamburg
Hamburg, Germany
Status: Recruiting
Contact: Henrik Suttman, PD Dr. - +49 40 6921440
Urologische Gemeinschaftspraxis
Heinsberg, Germany
Status: Recruiting
Contact: Aloys Lappenküper - +49 2452 3113
Urologische Praxis
Karlsruhe, Germany
Status: Recruiting
Contact: Michael Rug, Dr. - +49 721 22080
Urologische Gemeinschaftspraxis
Kempen, Germany
Status: Recruiting
Contact: Jan Marin, Dr. - +49 2152 899290
Urologische Gemeinschaftspraxis Studienzentrum Prüner Gang
Kiel, Germany
Status: Recruiting
Contact: Jan Lehmann, PD Dr. - +49 431 26042911
Urologische Gemeinschaftspraxis
Kirchheim/Teck, Germany
Status: Recruiting
Contact: Robert Rudolph, Dr. - +49 7021 3200
Urologische Facharztpraxis Cologne-Study-Group
Köln, Germany
Status: Recruiting
Contact: Jörg Klier, Dr. - +49 221 362025
Urologische Praxis
Langenfeld, Germany
Status: Recruiting
Contact: Eberhard Mumperow, Dr. - +49 2173 82426
Urologische Gemeinschaftspraxis
Leipzig, Germany
Status: Recruiting
Contact: Wito de Schulz, Dipl.-Med. - +49 341 90238577
Urologische Praxis
Lutherstadt Eisleben, Germany
Status: Recruiting
Contact: Ralf Eckert, Dr. - +49 3475 250059
Universitätsklinikum Gießen und Marburg GmbH Klinik für Urologie und Kinderurologie
Marburg/Lahn, Germany
Status: Recruiting
Contact: Axel Hegele, Prof. Dr. - +49 6421 5862575
Urologische Praxis
Marburg, Germany
Status: Recruiting
Contact: Maren Schwickardi, Dr. - +49 6421 96440
Urologische Facharztpraxis
Markkleeberg, Germany
Status: Recruiting
Contact: Matthias Schulze, Dr. - +49 341 3542755
Urologische Gemeinschaftspraxis
Michelstadt, Germany
Status: Recruiting
Contact: Alwin Weber, Dr. - +49 6061 925777
Urologische Gemeinschaftspraxis
Mühlacker, Germany
Status: Recruiting
Contact: Armin Weigl, Dr. - +49 7041 5622
Urologische Gemeinschaftspraxis
Mülheim, Germany
Status: Recruiting
Contact: Tim Schneider, Prof. Dr. - +49 208 94067900
Privatärztliche urologische Studienpraxis
Nürtingen, Germany
Status: Recruiting
Contact: Susan Feyerabend, Dr. - +49 170 3809233
Urologie PANDAMED
Remscheid, Germany
Status: Recruiting
Contact: Marc König, Dr. - +49 2191 291907
Urologische Gemeinschaftspraxis
Wesel, Germany
Status: Recruiting
Contact: Andreas Stammel, Dr. - +49 281 4755590
Klinikum Wolfsburg
Wolfsburg, Germany
Status: Not yet recruiting
Contact: Armin Leitenberger, Dr. - +49 5361 801740
Urologische Facharztpraxis
Würselen, Germany
Status: Recruiting
Contact: Thomas Pulte, Dr. - +49 2405 452680
Start Date
February 2015
Completion Date
October 2019
Sponsors
Abnoba Gmbh
Source
Abnoba Gmbh
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page