Study on superficial bladder carcinoma
First confirmatory study on mistletoe therapy in which a standard chemotherapy is compared with a mistletoe therapy.
A study recommended by the Arbeitsgemeinschaft Urologische Onkologie (AUO) [Urological
Oncology Study Group] of the Deutsche Krebsgesellschaft e.V. [German Cancer
Society] (AUO study No. AB 40/11).
Short title: TIM : Therapeutic instillation of a mistletoe extract
The co-ordinating investigator is Professor Herbert Rübben, University Hospital, Essen, Germany.
The sponsor of the study is ABNOBA GmbH.
For the first time, the study will compare the efficacy of a mistletoe preparation with an established Standard therapy in a so-called Phase III study 1).
Approximately 550 patients will be enrolled in the study in over 30 centres in Germany and abroad 2) and randomised to two treatment arms 3).
One of the preconditions for inclusion as a patient in the study (inclusion criterion) is a completed TUR (transurethral resection) of a urinary bladder tumour classified as stage Ta, and, subsequent to the TUR, early instillation of mitomycin shortly before the patient’s inclusion in the study.
The objective of the study is to compare the ‘one-year recurrence rate’ 4) after mitomycin therapy (= guideline-compliant or standard therapy) with the one-year recurrence rate after abnobaVISCUM therapy.
At the beginning of the study, patients in both treatment arms will be given 6 instillations of one of the preparations at 1-weekly intervals (induction phase). This will be followed by 7 instillations at 6-weekly intervals in the ABNOBA treatment arm and 4 instillations at 12-weekly intervals in the mitomycin treatment
arm. With these instillations, both the mitomycin therapy and therapy in the ABNOBA treatment arm will be concluded after approximately one year maintenance phase). A one-year follow-up period is planned.
During the study, all patients will undergo a total of 9 examinations, to allow early detection of any recurrence.
The first patients will be enrolled in 2014.
The study has been designated a ‘recommended study’ by the Urological Oncology Study Group (AUO) of the German Cancer Society.
The preliminary study on superficial bladder carcinoma, which has now been concluded and evaluated 5), indicates/leads to the assumption that abnobaVISCUM® has an effect comparable to that of mitomycin in the prevention of recurrence. Such a small preliminary study with few patients is also an ethical prerequisite for the TIM study with a large number of patients.
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Some of the German study centres are located in:
Berlin, Bonn, Cologne, Darmstadt, Duisburg, Eisleben, Erkrath, Essen, Göttingen, Hamburg, Heinsberg, Karlsruhe, Kempen, Kiel, Kirchheim, Langenfeld, Leipzig, Marburg, Markkleeberg, Michelstadt, Mühlacker, Nürtingen, Remscheid, Wesel, Wolfsburg and Würselen.
You can also find information on the study in the ‘EU Clinical Trials Register’ and at ‘www.clinicaltrials.gov’.
1) Clinical studies are divided into three phases, consisting of:
Phase 0: Pharmacokinetic and pharmacodynamic testing.
Phase I: Tests on the tolerability and safety of the medicine and additional pharmacokinetic and pharmacodynamic testing.
Phase II: Investigating a therapeutic concept (proof of concept, Phase IIa), determining the suitable therapeutic dose (dose finding, Phase IIb). Positive effects of therapy should be observable during this phase.
Phase IIa: Small-scale studies, to investigate efficacy and safety in selected patient groups and to determine the dosage.
Phase III: Significant proof of efficacy (pivotal study) for the marketing authorisation of the therapy; after Marketing authorisation, ongoing studies then become “Phase IIIb studies”.
Phase IV: Conducted with already authorised medicines for the authorised indication, e.g. to determine very rare adverse drug reactions, which are only identifiable in large patient collectives.
Easily understandable information on clinical studies can be found in the “Blue Guide” series from the Deutsche Krebsgesellschaft e.V. [German Cancer Society], Leaflet 60, “Clinical studies”.
2) Theodor Bilharz Institute, Cairo, Egypt.
3) “Randomised” or “Randomisation” means the random assignment of a patient to a study treatment arm in a way that is not open to influence.
4) The predicted recurrence rate of superficial bladder carcinoma in the first year of guideline-compliant therapy is 24 to 38%. Recurrence means that the tumour returns after successful removal.
5) In the preliminary study (Phase Ib/IIa), the safety and tolerability of various doses of the investigational medicinal product were investigated. Statistically unconfirmed indications of the investigational medicinal product’s efficacy
can be inferred from this study.