Treatment for superficial bladder cancer using mistletoe extract

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

This study is testing whether a mistletoe extract can help people with superficial bladder cancer stay cancer-free longer compared to a standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 548 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Abnoba Gmbh (Industry-sponsored)
• Locations: 5 sites (Giza and 4 other locations)
• Trial ID: NCT02106572 on ClinicalTrials.gov

What this trial studies

This phase III study aims to evaluate the effectiveness of abnobaVISCUM® 900 compared to Mitomycin C (MMC) in patients with superficial bladder carcinoma. It is a randomized, open-label, active-controlled trial that includes a screening period, a 12-month treatment phase, and a 12-month follow-up. The primary focus is on assessing the time to tumor recurrence and the safety profile of both treatments, alongside secondary measures such as quality of life and tumor grading upon recurrence.

Who should consider this trial

Good fit: Ideal candidates are patients with completely resected superficial bladder carcinoma (Stage Ta) classified as intermediate-risk according to EAU guidelines.

Not a fit: Patients with advanced bladder cancer or those who have not undergone complete resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could reduce the recurrence rate of superficial bladder cancer and improve patient quality of life.

How similar studies have performed: Other studies have explored similar treatments, but the specific use of abnobaVISCUM® 900 in this context is novel.

Eligibility criteria

Inclusion Criteria:

* Signed and dated written informed consent for data protection and willingness to participate and comply with the study protocol prior to any study-related procedures
* Completely resected (detrusor muscle in the TUR specimen according to need) superficial bladder carcinoma (Stage Ta) with classification as intermediate-risk according to the EAU (update 2013) and one immediately post operative intravesical MMC 40 mg or Epirubicin 50 mg instillation, completed re-resection if indicated
* Karnofsky Performance Status of 50% to 100% (corresponding to Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2)
* Life expectancy of ≥ 2 years at the time point of study inclusion
* Normal renal and liver function, normal cardiac and hematology profiles (patients with laboratory values slightly outside the reference range may be included, unless the investigator considers the abnormality as clinically significant)
* Female patients of childbearing potential must have a negative pregnancy test (β-human chorionic gonadotropin test) at Screening. Pregnancy during the treatment period including 12 weeks after the last instillation has to be excluded

Exclusion Criteria:

* Locally infiltrative or metastatic bladder tumor (Stage T2 or greater), low-risk Ta tumor (primary, solitary, LG/G1, \<3 cm, no CIS) or high-risk tumors according to EAU classification, update 2013 (T1; HG/G3; CIS; multiple and recurrent and large \[\>3 cm\] Ta G1/G2 tumors \[all conditions must be present at this point\], presence of upper urinary tract tumors or lesions which were not completely removed by TURB
* Urinary tract infection, benign prostatic obstruction grade II or III, neurogenic bladder, stress incontinence, bladder or urethral diverticula, fistulas or urethral stenosis
* Patients with acute systemic illness, such as inflammatory infections with fever \> 38°C
* Patients with previous recurrence of a superficial bladder cancer or radiotherapy of the bladder or other intravesical treatment within the last 6 months, or patients with previous mistletoe therapy
* Patients with other previous or co-existing malignancies or CIS
* Patients having any previous or concurrent therapy with a systemic chemo- / immunotherapeutical treatment regimen, in particular vinca alkaloids, bleomycine and doxorubicine, or patients who are treated with pyroxidine hydrochloride (vitamin B6)
* Untreated coagulation disorders or inadequate anticoagulation therapy
* Leukocyte count \< 4,000/mm3 or platelet count \< 100,000/mm3
* Serum creatinine \> 1.7 mg/dL
* Patients with known hypersensitivity to the excipients of the study medication (monosodium phosphate, disodium phosphate, ascorbic acid)
* Patients with a known hypersensitivity to mistletoe products and MMC
* Patients who were administered within a 4-week period before Visit 1 any other experimental drug under investigation
* Male patients planning to father a child or sperm donation from the first administration of study medication until 3 months after the last administration of the study medication
* Male patients unwilling to use barrier contraception ie, condoms and spermicide, from the day of first administration of the study medication until 12 weeks after administration of the study medication. In case the sexual relation is restricted to women fulfilling one of the criteria listed under inclusion criteria for female patients the barrier contraception is not necessary.
* Patients with a history of alcohol and / or drug abuse
* Patients who are unable to be regularly observed, not permitting adequate follow-up and compliance to the protocol

Where this trial is running

Giza and 4 other locations

• Theodor Bilharz Research Institute — Giza, Egypt (Recruiting)
• Clinic of Urology of the University Hospital of Essen — Essen, Germany (Recruiting)
• Urologische Gemeinschaftspraxis — Heinsberg, Germany (Recruiting)
• Urologische Praxis — Herzberg, Germany (Recruiting)
• Urologische Facharztpraxis — Würselen, Germany (Recruiting)

Study contacts

• Principal investigator: Jochen Hess, Prof. Dr. — Chief Medical Officer of the Urological Clinic of the University Hospital Essen
• Study coordinator: Juergen Eisenbraun, Dr.

Conditions Superficial Bladder Cancer; superficial bladder cancer; viscum album extract; mistletoe extract; abnobaVISCUM; recurrence rate