Clinical trial · Interventional
Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
Dose-Escalation-Study With abnobaVISCUM® Fraxini 2 (AVF2) as Intravesical Instillation in Patients With Superficial Bladder Cancer According to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) - Guidelines: a Phase Ib/IIa Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Superficial Bladder Cancer | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| abnobaVISCUM Fraxini | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- intravesical instillation of abnobaVISCUM Fraxini
- interventionNames
- Drug: abnobaVISCUM Fraxini
Primary outcomes (1)
- measure
- Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation
- timeFrame
- 6 weeks
- description
- The primary objective is to investigate the maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation in patients with superficial bladder cancer. The treatment schedule included 6 weekly instillations.
Secondary outcomes (2)
- measure
- Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection * Written informed consent for study participation and for documentation of disease data including further distribution of these data Exclusion Criteria: * Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS) * Intravesical instillation therapy within 6 months prior to study enrolment * Radiotherapy of the bladder prior to study enrolment * Contracted bladder (capacity less than 100 ml) * Non treated acute or chronic urinary tract infection * Allergy against mistletoe extract preparations * Subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml) * Severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse) * Pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception * Participation in another clinical study within 30 days prior to this study * Administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment * Chronic progressive infections (e. g. tuberculosis) * Pre-treatment with mistletoe extracts/mistletoe lectins
References
Publications (1)
- RESULTRose A, El-Leithy T, vom Dorp F, Zakaria A, Eisenhardt A, Tschirdewahn S, Rubben H. Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study. J Urol. 2015 Oct;194(4):939-43. doi: 10.1016/j.juro.2015.04.073. Epub 2015 Apr 22. PMID 25910967