In short
This article discusses a Phase III clinical trial investigating the use of Extract of Fresh Ash Mistletoe Herb (abnobaVISCUM®) in treating superficial bladder cancer. The study aims to compare the efficacy and safety of this innovative treatment with the standard Mitomycin C therapy. Researchers are particularly interested in examining the time to tumor recurrence and the overall safety profile of the mistletoe extract when administered directly into the bladder.
At a glance
- Study Type
- Phase III clinical trial
- Primary Objective
- Assess efficacy of abnobaVISCUM® 900 vs. Mitomycin C in superficial bladder cancer
- Primary Endpoint
- Time to tumor recurrence
- Secondary Objectives
- Safety, toxicity, treatment efficacy, quality of life
- Study Population
- Patients aged 18-85 with intermediate-risk superficial bladder cancer (Stage Ta)
- Treatment Administration
- Intravesical instillation
- Study Duration
- Approximately 2 years (6-week screening, 48-week treatment, 48-week follow-up)
- Key Inclusion Criteria
- Completely resected superficial bladder cancer, intermediate-risk, post-TURB
- Key Exclusion Criteria
- Advanced bladder cancer, hypersensitivity to study medications, recent experimental treatments
Overview of the Treatment
The EXTRACT OF FRESH ASH MISTLETOE HERB is being studied as a potential treatment for superficial bladder cancer. This extract is derived from mistletoe plants that grow on ash trees and is being investigated under the brand name abnobaVISCUM® 900. The treatment is administered directly into the bladder, a method known as intravesical instillation.
Medical Condition Treated
This treatment is being studied for patients with superficial bladder cancer, specifically those with: Stage Ta tumors (tumors confined to the inner lining of the bladder) Intermediate-risk classification according to the European Association of Urology (EAU) No presence of carcinoma in situ (CIS) or G3 (high-grade) tumors Patients must have undergone complete tumor removal through a procedure called transurethral resection of bladder tumor (TURB) and received one post-operative intravesical instillation of either Mitomycin C or Epirubicin.
Study Objectives
The main goals of the study are: To assess how effective abnobaVISCUM® 900 is compared to Mitomycin C (MMC) in treating superficial bladder cancer. The primary measure of effectiveness is the time it takes for the tumor to recur. To evaluate the safety of abnobaVISCUM® 900 compared to MMC, focusing on side effects and how well patients tolerate the treatment. To assess other factors such as the likelihood of cancer recurrence or progression after one year, tumor grading, and the patient's quality of life.
Eligibility Criteria
To participate in this study, patients must meet certain criteria, including: Age between 18 and 85 years Completely resected superficial bladder cancer (Stage Ta) Intermediate-risk classification Adequate overall health status (Karnofsky Performance Status of 50% to 100%) Life expectancy of at least 2 years Normal kidney and liver function There are also several conditions that would exclude a patient from participating, such as having advanced bladder cancer, certain other medical conditions, or previous treatments that might interfere with the study.
Treatment Details
The study is designed as follows: A 6-week screening period to determine eligibility A 48-week treatment period where patients receive either abnobaVISCUM® 900 or Mitomycin C A 48-week follow-up period to monitor long-term effects The mistletoe extract (abnobaVISCUM® 900) is administered as a solution for injection directly into the bladder. The maximum daily dose is 45 ml, with a total maximum dose of 675 ml over the treatment period.
Effectiveness Measures
The main measure of how well the treatment works is the time to tumor recurrence. This means how long it takes for the cancer to come back after treatment. Other measures include: The estimated risk of cancer recurrence and progression after one year Changes in tumor grading (how abnormal the cancer cells look under a microscope) The patient's quality of life, measured using specific questionnaires (EORTC QLQ-C30 and BLS24)
Safety and Side Effects
The study closely monitors the safety of the treatment by: Tracking any adverse events (side effects) using a standardized system called the Common Terminology Criteria for Adverse Events (CTCAE) Performing regular laboratory tests to check blood counts, kidney and liver function Assessing how well patients tolerate the treatment overall Patients should be aware that there may be risks associated with the treatment, including potential allergic reactions to mistletoe products or the other ingredients in the medication.