Superficial Bladder CancerPhase 1/2NCT02007005
Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
A Phase 1/2 study testing abnobaVISCUM Fraxini in people with Superficial Bladder Cancer, run by Abnoba Gmbh at 2 sites in 2 countries.
Trial summary
The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Superficial Bladder Cancer
- What is being tested?
- abnobaVISCUM Fraxini
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2004to Sep 2013
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection
- Written informed consent for study participation and for documentation of disease data including further distribution of these data
Who cannot join
- Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS)
- Intravesical instillation therapy within 6 months prior to study enrolment
- Radiotherapy of the bladder prior to study enrolment
- Contracted bladder (capacity less than 100 ml)
- Non treated acute or chronic urinary tract infection
- Allergy against mistletoe extract preparations
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- Subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml)
- Severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse)
- Pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception
- Participation in another clinical study within 30 days prior to this study
- Administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment
- Chronic progressive infections (e. g. tuberculosis)
- Pre-treatment with mistletoe extracts/mistletoe lectins
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Clinic of Urology of the University Hospital of Essen
Essen, 45122
About this study
Official title: Dose-Escalation-Study With abnobaVISCUM® Fraxini 2 (AVF2) as Intravesical Instillation in Patients With Superficial Bladder Cancer According to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) - Guidelines: a Phase Ib/IIa Study
The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.
Read the detailed description
A dose-escalation-study according ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) with different concentrations of abnobaVISCUM® Fraxini is conducted in two hospitals in Germany and Egypt. Patients with superficial bladder cancer TaG1/G2 or T1G1/G2 are enclosed after TUR-B (transurethral resection bladder). The tolerability of the different concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. A direct antitumoral effect is assessed on a single marker tumor left in the bladder after a complete TUR of all other lesions according a study design established by the EORTC-GENITO-URINARY GROUP (European Organisation for Research and Treatment of Cancer). A re-TUR is conducted after 12 weeks. Tumor response is measured by biopsy of the marker lesion and by cytology. Safety of the instillations is measured by analysis of adverse events, vital signs and clinical laboratory tests. After treatment of a cohort is finished a safety evaluation is conducted to decide about the increase to the next dosage.
- Conditions
- Superficial Bladder Cancer
- Being tested
- abnobaVISCUM Fraxini
- Keywords
- superficial bladder cancer, mistletoe extract, maximum tolerated dose, marker tumor, remission, 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 FraxiniDrug
Also called viscum album extract, mistletoe extract, abnobaVISCUM
intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | intravesical instillation of abnobaVISCUM Fraxini Receives: Drug: abnobaVISCUM Fraxini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation
The primary objective is to investigate the maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation in patients with superficial bladder cancer. The treatment schedule included 6 weekly instillations.
Measured: 6 weeks
Secondary outcomes (2)
Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation
Secondary objectives are to investigate the local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation. Main variables of safety analysis are adverse events, vital signs and clinical laboratory tests.
Measured: 6 weeks
Influence on remission and influence on the one year recurrence rate of abnobaVISCUM Fraxini for intravesical instillation
Secondary objectives are to investigate the influence on remission and influence on the one year recurrence rate measured by histological examination of biopsies of the marker lesion, cytology and cystoscopy.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2004
- Primary completionFeb 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abnoba Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert Ruebben, Prof.Dr.Dr., Study director, Director of the Urological Clinic of the University Hospital Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007005
- Sponsor's protocol ID
- AB01
- Status last verified
- May 2015
- First submitted
- 5 Dec 2013
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rose A, El-Leithy T, vom Dorp F, Zakaria A, Eisenhardt A, Tschirdewahn S, Rubben H. Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study. J Urol. 2015 Oct;194(4):939-43. doi: 10.1016/j.juro.2015.04.073. Epub 2015 Apr 22.
PubMed 25910967
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalation-Study With abnobaVISCUM® Fraxini 2 (AVF2) as Intravesical Instillation in Patients With Superficial Bladder Cancer According to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) - Guidelines: a Phase Ib/IIa Study
- ClinicalTrials.gov ID
- NCT02007005
- Acronym / sponsor ID
- AB01
- Conditions
- Superficial Bladder Cancer
- Keywords
- superficial bladder cancer, mistletoe extract, maximum tolerated dose, marker tumor, remission, recurrence rate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Abnoba GmbhIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Dec 2013 (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 Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.
Detailed description
A dose-escalation-study according ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) with different concentrations of abnobaVISCUM® Fraxini is conducted in two hospitals in Germany and Egypt. Patients with superficial bladder cancer TaG1/G2 or T1G1/G2 are enclosed after TUR-B (transurethral resection bladder). The tolerability of the different concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. A direct antitumoral effect is assessed on a single marker tumor left in the bladder after a complete TUR of all other lesions according a study design established by the EORTC-GENITO-URINARY GROUP (European Organisation for Research and Treatment of Cancer). A re-TUR is conducted after 12 weeks. Tumor response is measured by biopsy of the marker lesion and by cytology. Safety of the instillations is measured by analysis of adverse events, vital signs and clinical laboratory tests. After treatment of a cohort is finished a safety evaluation is conducted to decide about the increase to the next dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: abnobaVISCUM Fraxiniintravesical instillation of abnobaVISCUM Fraxini |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection
- Written informed consent for study participation and for documentation of disease data including further distribution of these data
Key exclusion criteria (13 listed)
- Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS)
- Intravesical instillation therapy within 6 months prior to study enrolment
- Radiotherapy of the bladder prior to study enrolment
- Contracted bladder (capacity less than 100 ml)
- Non treated acute or chronic urinary tract infection
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 FraxiniAlso: viscum album extract, mistletoe extract, abnobaVISCUMintravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs | Drug | Dose escalation |
Primary outcome
Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation
Time frame: 6 weeks
The primary objective is to investigate the maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation in patients with superficial bladder cancer. The treatment schedule included 6 weekly instillations.
2 secondary outcomes
Local and systemic tolerability of different concentrations of abnobaVISCUM Fraxini for intravesical instillation
Time frame: 6 weeks
Influence on remission and influence on the one year recurrence rate of abnobaVISCUM Fraxini for intravesical instillation
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Results publication: PubMed 25910967Rose A, El-Leithy T, vom Dorp F, Zakaria A, Eisenhardt A, Tschirdewahn S, Rubben H. Mistletoe Plant Extract in Patients with Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study. J Urol. 2015 Oct;194(4):939-43. doi: 10.1016/j.juro.2015.04.073. Epub 2015 Apr 22.
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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.
Herbert Ruebben, Prof.Dr.Dr. study director
Director of the Urological Clinic of the University Hospital Essen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing abnobaVISCUM Fraxini in people with Superficial Bladder Cancer, run by Abnoba Gmbh at 2 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerable concentration of abnobaVISCUM Fraxini for intravesical instillation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007005, which also lists 1 linked publication.
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 6 May 2015.