Superficial Bladder CancerPhase 3TIMNCT02106572
Therapeutic Instillation of Mistletoe
A Phase 3 study testing abnobaVISCUM 900 and Mitomycin C in people with Superficial Bladder Cancer, run by Abnoba Gmbh at 5 sites in 2 countries.
Trial summary
The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Superficial Bladder Cancer
- What is being tested?
- abnobaVISCUM 900 and Mitomycin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Apr 2015to 24 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Clinic of Urology of the University Hospital of Essen
Essen, 45122
Urologische Gemeinschaftspraxis
Heinsberg, 52525
Urologische Praxis
Herzberg, 37412
Urologische Facharztpraxis
Würselen, 52146
About this study
Official title: Intravesical Mistletoe Extract in Superficial Bladder Cancer: A Phase III Efficacy Study
The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, the tumor grading in case of a recurrence and by measurement of Quality of Life.
Read the detailed description
This is a randomized, open-label, active-controlled, prospective, multinational Phase III confirmative study with 2 treatment groups and an adaptive design (Bauer and Köhne, 1994). The study is designed to compare the efficacy of treatment with abnobaVISCUM® 900 with Mitomycin C (MMC). Patients with completely resected superficial bladder carcinoma (Stage Ta) with an intermediate risk classification according to the European Association of Urology (EAU, update 2013) and with one immediately post operative MMC 40 mg or Epirubicin 50 mg intravesical instillation will be eligible for inclusion in the study.
The study comprises a screening period of not more than 6 weeks, a treatment period of 12 months for abnobaVISCUM® 900 and MMC and a follow-up period of 12 months. Patients will be screened within 6 weeks after the transurethral resection of the bladder (TURB) and the immediately post operative MMC 40 mg or Epirubicin 50 mg intravesical instillation. A re-resection should be performed before inclusion if indicated. Every patient is to provide written informed consent before any study related procedures will be performed.
- Conditions
- Superficial Bladder Cancer
- Being tested
- abnobaVISCUM 900, Mitomycin C
- Keywords
- superficial bladder cancer, viscum album extract, mistletoe extract, abnobaVISCUM, recurrence rate
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abnobaVISCUM 900Drug
Also called viscum album extract, mistletoe extract, abnobaVISCUM
intravesical instillation of abnobaVISCUM 900 13 times during treatment period
Mitomycin CDrug
Also called MMC, Mitomycin
intravesical instillation of Mitomycin C 10 times during treatment period
| Study group | Role | What they receive |
|---|---|---|
| abnobaVISCUM 900 | Experimental | intravesical instillation of abnobaVISCUM 900 Receives: Drug: abnobaVISCUM 900 |
| Mitomycin C | Active comparator | intravesical instillation of Mitomycin C Receives: Drug: Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tumor recurrence
The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.
Measured: up to two years
Secondary outcomes (4)
Toxicity and tolerability of the study medication
The secondary objective, namely safety including toxicity and tolerability of the study medication, will be assessed by the monitoring of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE), laboratory assessments (hematology, biochemistry and urinalysis) and a global judgment of tolerability.
Measured: up to two years
Prognosis after 1 year for recurrence and progression
A secondary efficacy endpoint is prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator.
Measured: 1 year
Quality of Life with the EORTC QLQ-C30 and BLS24 Quality of Life Questionnaires
A secondary efficacy endpoint is measurement of Quality of Life with the EORTC QLQ-C30 and BLS24 questionnaires.
Measured: up to two years
Tumor grading
A secondary efficacy endpoint is the tumor grading in case of a recurrence by cytology, ultrasound, and cystoscopy.
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2015
- Primary completion24 Mar 2026
- Study completion24 Apr 2026
Why it stopped: The study was terminated because the required number of patients cannot be reached in the foreseeable future. Recruitment was not stopped due to safety issues. Follow-up for all patients was completed according protocol including safety monitoring.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abnoba Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jochen Hess, Prof. Dr., Principal investigator, Chief Medical Officer of the Urological Clinic of the University Hospital Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106572
- Sponsor's protocol ID
- AB03
- Other IDs
- 2013-003446-16, 2023-503718-66-00, 2023
- Acronym
- TIM
- Status last verified
- May 2026
- First submitted
- 4 Apr 2014
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Mistletoe Extract in Superficial Bladder Cancer: A Phase III Efficacy Study
- ClinicalTrials.gov ID
- NCT02106572
- Acronym / sponsor ID
- TIM / AB03
- Conditions
- Superficial Bladder Cancer
- Keywords
- superficial bladder cancer, viscum album extract, mistletoe extract, abnobaVISCUM, recurrence rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because the required number of patients cannot be reached in the foreseeable future. Recruitment was not stopped due to safety issues. Follow-up for all patients was completed according protocol including safety monitoring.
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Abnoba GmbhIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, the tumor grading in case of a recurrence and by measurement of Quality of Life.
Detailed description
This is a randomized, open-label, active-controlled, prospective, multinational Phase III confirmative study with 2 treatment groups and an adaptive design (Bauer and Köhne, 1994). The study is designed to compare the efficacy of treatment with abnobaVISCUM® 900 with Mitomycin C (MMC). Patients with completely resected superficial bladder carcinoma (Stage Ta) with an intermediate risk classification according to the European Association of Urology (EAU, update 2013) and with one immediately post operative MMC 40 mg or Epirubicin 50 mg intravesical instillation will be eligible for inclusion in the study.
The study comprises a screening period of not more than 6 weeks, a treatment period of 12 months for abnobaVISCUM® 900 and MMC and a follow-up period of 12 months. Patients will be screened within 6 weeks after the transurethral resection of the bladder (TURB) and the immediately post operative MMC 40 mg or Epirubicin 50 mg intravesical instillation. A re-resection should be performed before inclusion if indicated. Every patient is to provide written informed consent before any study related procedures will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abnobaVISCUM 900 | Experimental | Drug: abnobaVISCUM 900intravesical instillation of abnobaVISCUM 900 |
| Mitomycin C | Active comparator | Drug: Mitomycin Cintravesical instillation of Mitomycin C |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abnobaVISCUM 900Also: viscum album extract, mistletoe extract, abnobaVISCUMintravesical instillation of abnobaVISCUM 900 13 times during treatment period | Drug | abnobaVISCUM 900 |
| Mitomycin CAlso: MMC, Mitomycinintravesical instillation of Mitomycin C 10 times during treatment period | Drug | Mitomycin C |
Primary outcome
Time to tumor recurrence
Time frame: up to two years
The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.
4 secondary outcomes
Toxicity and tolerability of the study medication
Time frame: up to two years
Prognosis after 1 year for recurrence and progression
Time frame: 1 year
Quality of Life with the EORTC QLQ-C30 and BLS24 Quality of Life Questionnaires
Time frame: up to two years
Tumor grading
Time frame: up to two years
Results and safety
The study was stopped early (reason given: The study was terminated because the required number of patients cannot be reached in the foreseeable future. Recruitment was not stopped due to safety issues. Follow-up for all patients was completed according protocol including safety monitoring.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Hess, Prof. Dr. principal investigator
Chief Medical Officer of the Urological Clinic of the University Hospital Essen
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing abnobaVISCUM 900 and Mitomycin C in people with Superficial Bladder Cancer, run by Abnoba Gmbh at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated because the required number of patients cannot be reached in the foreseeable future. Recruitment was not stopped due to safety issues. Follow-up for all patients was completed according protocol including safety monitoring.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to tumor recurrence (time frame: up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.