Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superfici… (NCT02007005) | Clinical Trial Compass
CompletedPhase 1/2
Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
Egypt, Germany37 participantsStarted 2004-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation