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Trial record 2 of 4 for:    ABNOBA

Therapeutic Instillation of Mistletoe (TIM)

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ClinicalTrials.gov Identifier: NCT02106572
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Abnoba Gmbh

Brief 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.

Condition or disease Intervention/treatment Phase
Superficial Bladder Cancer Drug: abnobaVISCUM 900 Drug: Mitomycin C Phase 3

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 6 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 6 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blind Review in accordance with with ICH-Biostatistics Guideline ICH E9
Primary Purpose: Treatment
Official Title: Intravesical Mistletoe Extract in Superficial Bladder Cancer: A Phase III Efficacy Study
Study Start Date : February 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: abnobaVISCUM 900
intravesical instillation of abnobaVISCUM 900
Drug: abnobaVISCUM 900
intravesical instillation of abnobaVISCUM 900 13 times during treatment period
Other Names:
  • viscum album extract
  • mistletoe extract
  • abnobaVISCUM

Active Comparator: Mitomycin C
intravesical instillation of Mitomycin C
Drug: Mitomycin C
intravesical instillation of Mitomycin C 10 times during treatment period
Other Names:
  • MMC
  • Mitomycin




Primary Outcome Measures :
  1. Time to tumor recurrence [ Time Frame: up to two years ]
    The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.


Secondary Outcome Measures :
  1. Toxicity and tolerability of the study medication [ Time Frame: up to two years ]
    The secondary objective, namely safety including toxicity and tolerability of the study medication, will be assessed by the monitoring of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE), laboratory assessments (hematology, biochemistry and urinalysis) and a global judgment of tolerability.

  2. Prognosis after 1 year for recurrence and progression [ Time Frame: 1 year ]
    A secondary efficacy endpoint is prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator.

  3. Quality of Life [ Time Frame: up to two years ]
    A secondary efficacy endpoint is measurement of Quality of Life with the EORTC QLQ-C30 and BLS24 questionnaires.

  4. Tumor grading [ Time Frame: up to two years ]
    A secondary efficacy endpoint is the tumor grading in case of a recurrence by cytology, ultrasound, and cystoscopy.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 according to need) 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. In case the sexual relation is restricted to women fulfilling one of the criteria listed under inclusion criteria for female patients the barrier contraception is not necessary.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106572


Contacts
Contact: Juergen Eisenbraun, Dr. +49 7231 315050 eisenbraun@abnoba.de

Locations
Egypt
Theodor Bilharz Research Institute Recruiting
Giza, Egypt, 12411
Contact: Tarek El Leithy, Prof. Dr.    +2 01222117206      
Principal Investigator: Tarek El Leithy, Prof. Dr.         
Sub-Investigator: Hani Nour, Dr.         
Germany
Urologische Gemeinschaftspraxis Recruiting
Wilmersdorf, Berlin, Germany, 14197
Contact: Jörg Schröder, Dr.    +49 30 88663500      
Principal Investigator: Jörg Schneider, Dr.         
Sub-Investigator: Frank König, PD Dr.         
Universitätsklinikum Freiburg Recruiting
Freiburg, Breisgau, Germany, 79106
Contact: Wolfgang Schultze-Seemann, Prof. Dr.    +49 761 27028920      
Principal Investigator: Wolfgang Schultze-Seemann, Prof. Dr.         
Sub-Investigator: Cordula Jilg, PD Dr.         
Kliniken Nordoberpfalz AG, Klinikum Weiden Recruiting
Weiden, Oberpfalz, Germany, 92637
Contact: Thoeodor Klotz, Prof. Dr.    +49 0961 3033302      
Principal Investigator: Theodor Klotz, Prof. Dr.         
Sub-Investigator: Siegfried Heida, Dr.         
Urologische Praxis Recruiting
Berlin, Germany, 10711
Contact: Frank Christoph, PD Dr.    +49 30 8915025      
Principal Investigator: Frank Christoph, PD Dr.         
Sub-Investigator: Swetlana Kantor, MD         
Urologische Gemeinschaftspraxis Recruiting
Berlin, Germany, 13187
Contact: Roger Zillmann, Dipl.-Med.    +49 30 4853868      
Principal Investigator: Roger Zillmann, Dipl.-Med.         
Sub-Investigator: Peter Kirschner, Dr.         
Urologische Praxis Bonn-Rhein-Sieg Recruiting
Bonn, Germany, 53177
Contact: Reinhold Schaefer, Dr.    +49 228 957370      
Principal Investigator: Reinhold Schaefer, Dr.         
Sub-Investigator: Philipp Lossin, Dr.         
Urologicum Duisburg Recruiting
Duisburg, Germany, 47179
Contact: Andreas Swoboda, Dr.    +49 203 50030420      
Principal Investigator: Andreas Swoboda, Dr.         
Sub-Investigator: Eva Hellmis, Dr.         
Urologische Praxis Recruiting
Eisleben Lutherstadt, Germany, 06295
Contact: Ralf Eckert, Dr.    +49 3475 250059      
Principal Investigator: Ralf Eckert, Dr.         
Sub-Investigator: Andreas Wicht, Dr.         
Überörtliche urologische Gemeinschaftspraxis Recruiting
Erkrath, Germany, 40699
Contact: Wolfgang Rulf, Dr.    +49 2104 43048      
Principal Investigator: Wolfgang Rulf, Dr.         
Sub-Investigator: Wolfgang Langhorst, Dr.         
Clinic of Urology of the University Hospital of Essen Recruiting
Essen, Germany, 45122
Contact: Stephan Tschirdewahn, Dr.    +49 201 7233210      
Principal Investigator: Stephan Tschirdewahn, Dr.         
Sub-Investigator: Christian Niedworok, PD Dr.         
Urologische Praxis Not yet recruiting
Hamburg, Germany, 22159
Contact: Maryam Aalamian-Mattheis, Dr.    +49 172 6523098      
Principal Investigator: Maryam Aalamian-Mattheis, Dr.         
Sub-Investigator: Saeed Pooyeh, Dr.         
Urologikum Hamburg Recruiting
Hamburg, Germany, 22399
Contact: Henrik Suttman, PD Dr.    +49 40 6921440      
Principal Investigator: Henrik Suttmann, PD Dr.         
Sub-Investigator: Rolf Eichenauer, Dr.         
Urologische Gemeinschaftspraxis Recruiting
Heinsberg, Germany, 52525
Contact: Aloys Lappenküper    +49 2452 3113      
Principal Investigator: Aloys Lappenküper, MD         
Sub-Investigator: Thomas Kretz, MD         
Urologische Praxis Recruiting
Herzberg, Germany, 37412
Contact: Thorsten Werner, Dr.    +49 5521 71212      
Principal Investigator: Thorsten Werner, Dr.         
Sub-Investigator: Andreas Herz, Dr.         
Universitätsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Marc-Oliver Grimm, Prof. Dr.    +49 3641 935206      
Principal Investigator: Marc-Oliver Grimm, Prof. Dr.         
Sub-Investigator: Susan Foller, Dr.         
Urologische Praxis Recruiting
Karlsruhe, Germany, 76133
Contact: Michael Rug, Dr.    +49 721 22080      
Principal Investigator: Michael Rug, Dr.         
Sub-Investigator: Thomas Frangenheim, Dr.         
Urologische Gemeinschaftspraxis Recruiting
Kempen, Germany, 47906
Contact: Jan Marin, Dr.    +49 2152 899290      
Principal Investigator: Jan Marin, Dr.         
Sub-Investigator: Gundula Linnenbrink, Dr.         
Urologische Gemeinschaftspraxis Studienzentrum Prüner Gang Recruiting
Kiel, Germany, 24103
Contact: Jan Lehmann, PD Dr.    +49 431 26042911      
Principal Investigator: Jan Lehmann, PD Dr.         
Sub-Investigator: Sebastian Bach, MD         
Urologische Gemeinschaftspraxis Recruiting
Kirchheim unter Teck, Germany, 73230
Contact: Robert Rudolph, Dr.    +49 7021 3200      
Principal Investigator: Robert Rudolph, Dr.         
Sub-Investigator: Ulrich Wörner, Dr.         
Urologische Facharztpraxis Cologne-Study-Group Recruiting
Köln, Germany, 50968
Contact: Jörg Klier, Dr.    +49 221 362025      
Principal Investigator: Jörg Klier, Dr.         
Sub-Investigator: Sassan Nazari, Dr.         
Urologische Praxis Recruiting
Langenfeld, Germany, 40764
Contact: Eberhard Mumperow, Dr.    +49 2173 82426      
Principal Investigator: Eberhard Mumperow, Dr.         
Sub-Investigator: Wolfgang Rulf, Dr.         
Urologische Gemeinschaftspraxis Recruiting
Leipzig, Germany, 04229
Contact: Wito de Schulz, Dipl.-Med.    +49 341 90238577      
Principal Investigator: Wito de Schulz, Dipl.-Med.         
Sub-Investigator: Detlef Nietzsch, Dr.         
Universitätsklinikum Gießen und Marburg GmbH Klinik für Urologie und Kinderurologie Recruiting
Marburg/Lahn, Germany, 35033
Contact: Axel Hegele, Prof. Dr.    +49 6421 5862575      
Principal Investigator: Axel Hegele, Prof. Dr.         
Sub-Investigator: Rainer Häußermann, Dr.         
Urologische Praxis Recruiting
Marburg, Germany, 35039
Contact: Maren Schwickardi, Dr.    +49 6421 96440      
Principal Investigator: Maren Schwickardi, Dr.         
Sub-Investigator: Martin Ludwig, Dr.         
Urologische Facharztpraxis Recruiting
Markkleeberg, Germany, 04416
Contact: Matthias Schulze, Dr.    +49 341 3542755      
Principal Investigator: Matthias Schulze, Dr.         
Sub-Investigator: Sylvio Szymula, Dr.         
Urologische Gemeinschaftspraxis Recruiting
Michelstadt, Germany, 64720
Contact: Alwin Weber, Dr.    +49 6061 925777      
Principal Investigator: Alwin Weber, Dr.         
Sub-Investigator: Ingo Drehmer, Dr.         
Urologische Gemeinschaftspraxis Recruiting
Mühlacker, Germany, 75417
Contact: Armin Weigl, Dr.    +49 7041 5622      
Principal Investigator: Armin Weigl, Dr.         
Sub-Investigator: Thomas Helder, Dr.         
Urologische Gemeinschaftspraxis Recruiting
Mülheim, Germany, 45468
Contact: Tim Schneider, Prof. Dr.    +49 208 94067900      
Principal Investigator: Tim Schneider, Prof. Dr.         
Principal Investigator: Elke Stagge, Dr.         
Privatärztliche urologische Studienpraxis Recruiting
Nürtingen, Germany, 72622
Contact: Susan Feyerabend, Dr.    +49 170 3809233      
Principal Investigator: Susan Feyerabend, Dr.         
Sub-Investigator: Michael Feyerabend, Dr.         
Urologie PANDAMED Recruiting
Remscheid, Germany, 42853
Contact: Marc König, Dr.    +49 2191 291907      
Principal Investigator: Marc König, Dr.         
Sub-Investigator: Stefan Schraa, Dr.         
Urologische Gemeinschaftspraxis - URONEUM Recruiting
Reutlingen, Germany, 72764
Contact: Simone Maier, Dr.    +49 07121 694980      
Principal Investigator: Simone Maier, Dr.         
Sub-Investigator: Thomas Schradin, Dr.         
Urologische Gemeinschaftspraxis Recruiting
Wesel, Germany, 46483
Contact: Andreas Stammel, Dr.    +49 281 4755590      
Principal Investigator: Andreas Stammel, Dr.         
Sub-Investigator: Miguel Garcia Schürmann, Dr.         
Urologische Praxisgemeinschaft Recruiting
Wolfsburg, Germany, 38440
Contact: Jens Telle, Dipl.-Med.    +49 05361 3769980      
Principal Investigator: Jens Telle, Dipl.-Med.         
Sub-Investigator: Thomas Reichelt, MD         
Urologische Gemeinschaftspraxis DGU MVZ Recruiting
Wuppertal, Germany, 42103
Contact: Jochen Gleißner, Dr.    +49 0202 248060      
Principal Investigator: Jochen Gleißner, Dr.         
Sub-Investigator: Dirk Wienhold, MD         
Urologische Facharztpraxis Recruiting
Würselen, Germany, 52146
Contact: Thomas Pulte, Dr.    +49 2405 452680      
Principal Investigator: Thomas Pulte, Dr.         
Sub-Investigator: Stephan Wolter, Dr.         
Sponsors and Collaborators
Abnoba Gmbh
Investigators
Principal Investigator: Stephan Tschirdewahn, Dr. Senior Physician of the Urological Clinic of the University Hospital Essen

Responsible Party: Abnoba Gmbh
ClinicalTrials.gov Identifier: NCT02106572     History of Changes
Other Study ID Numbers: AB03
2013-003446-16 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Abnoba Gmbh:
superficial bladder cancer
viscum album extract
mistletoe extract
abnobaVISCUM
recurrence rate

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
Viscum album peptide
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents