Brief Title: Therapeutic Instillation of Mistletoe

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Time to tumor recurrence

Primary Outcome 1 - Timeframe: up to two years

CONDITION

• Superficial Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jochen Hess, Prof. Dr.

Role: Principal Investigator

Affiliation: Chief Medical Officer of the Urological Clinic of the University Hospital Essen

Overall Contact

Name: Juergen Eisenbraun, Dr.

Phone: +49 7233 7043 200

Email: [email protected]

LOCATION