Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Urinary Bladder Neoplasms

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

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Anti-Infective Agents

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All Drugs and Chemicals

Herbal and Botanical

Viscum album peptide

Mitomycins

Mitomycin

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European Mistletoe

intravesical instillation of abnobaVISCUM 900

intravesical instillation of abnobaVISCUM 900 13 times during treatment period

abnobaVISCUM 900

intravesical instillation of Mitomycin C 10 times during treatment period

Mitomycin C

Juergen Eisenbraun, Dr.

Tarek El Leithy, Prof. Dr.

Hani Nour, Dr.

Jochen Hess, Prof. Dr.

Boris Hadaschik, Prof. Dr.

Aloys Lappenküper

Aloys Lappenküper, MD

Thomas Kretz, MD

Thorsten Werner, Dr.

Arian Farid, Dr.

Thomas Pulte, Dr.

Stephan Wolter, Dr.

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.

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 or Epirubicin 50 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 or Epirubicin 50 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.

Blind Review in accordance with with ICH-Biostatistics Guideline ICH E9

Therapeutic Instillation of Mistletoe

Intravesical Mistletoe Extract in Superficial Bladder Cancer: A Phase III Efficacy Study

The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.

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.

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.

A secondary efficacy endpoint is measurement of Quality of Life with the EORTC QLQ-C30 and BLS24 questionnaires.

A secondary efficacy endpoint is the tumor grading in case of a recurrence by cytology, ultrasound, and cystoscopy.

Abnoba Gmbh

Spots Global Cancer Trial Database for abnobaviscum 900