NCT02106572

Therapeutic Instillation of Mistletoe

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 548 (estimated)
• Sponsor: Abnoba Gmbh · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Superficial Bladder Cancer

Interventions

Type	Name	Description
DRUG	abnobaVISCUM 900	intravesical instillation of abnobaVISCUM 900 13 times during treatment period
DRUG	Mitomycin C	intravesical instillation of Mitomycin C 10 times during treatment period

Timeline

• Start date: 2015-04-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2014-04-08
• Last updated: 2025-07-23

Locations

5 sites across 2 countries: Egypt, Germany