Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abnoba Gmbh
• Treatments: Viscum album peptide

Criteria

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