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The study evaluates the efficacy of the therapy of Mistletoe Extract in patients with superficial bladder cancer. There fore the Mistletoe Extract will be administered directly into the bladder.
EU CTIS ID: 2023-503718-66-00
What this study is testing
The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma. Primary efficacy criterion will be the time to tumor recurrence.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Male or female outpatients
- Aged ≥ 18 to ≤ 85 years
- 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, see Appendix 4) and one immediately post operative intravesical MMC instillation of 40 mg or Epirubicin 50 mg (only Poland), completed re-resection (without another immediate MMC instillation) if indicated
- Have a Karnofsky Performance Status of 50% to 100% (corresponding to ECOG Performance Status of 0 to 2)
- Have a life expectancy of ≥ 2 years at the time point of study inclusion
You likely can't join if
- Have 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 (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
- 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 8. for female patients the barrier contraception is not necessary.
See the full eligibility criteria
Who can join
- 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
- Male or female outpatients
- Aged ≥ 18 to ≤ 85 years
- 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, see Appendix 4) and one immediately post operative intravesical MMC instillation of 40 mg or Epirubicin 50 mg (only Poland), completed re-resection (without another immediate MMC instillation) if indicated
- Have a Karnofsky Performance Status of 50% to 100% (corresponding to ECOG Performance Status of 0 to 2)
- Have a life expectancy of ≥ 2 years at the time point of study inclusion
- Have 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-HCG test) at screening. All female patients must fulfill one of the following criteria: • Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone (FSH) levels in the laboratory defined post-menopausal range • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation • Sexually active women of childbearing potential must use an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, spermicides]) from the time point of signing informed consent until 12 weeks after the last instillation
What rules you out
- Have 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 (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
- 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 8. 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
- Have 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 (129.6 μmol/l)
The study team makes the final eligibility decision.
Where it's taking place
- Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.