Bladder CarcinomaNCT02202044
Sequential Intravesical Bacillus Calmette-Guérin and Electromotive Mitomycin-C After Transuretheral Resection
A study testing Intravesical BCG and EMDA/MMC in people with Bladder Carcinoma, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure is disease recurrence rate. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Bladder Carcinoma
- What is being tested?
- Intravesical BCG and EMDA/MMC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Feb 2015to 11 May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After a restaging TURBT patients with histologically proven primary high grade (grade3) and/or pT1 transitional cell carcinoma of the bladder, with or without pTis and pTis alone are regarded as being at high risk for tumour recurrence and progression.
- Patients may enroll in this study if they are thought to have no residual disease after TURBT.
- Age 18 years or over
- Adequate bone-marrow reserve- ECOG performance status between 0 and 2
- Patients who are known PPD positive will be screened for active tuberculosis prior to starting treatment with BCG.
Who cannot join
- known allergy to BCG or MMC
- prior systemic infection with BCG
- prior or concomitant urothelial tumours of the upper urinary tract or urethra
- previous muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder
- bladder capacity of less than 200 ml
- untreated urinary-tract infection
Show all 19Show fewer
- severe systemic infection (ie, sepsis)
- known HIV-positivity; therapy with immunosuppressive agents
- urethral strictures that would prevent endoscopic procedures and repeated catheterisation
- upper urinary tract disease (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures a risk
- previous radiotherapy to the pelvis
- other concurrent chemotherapy
- treatment with radiotherapy-response or biological-response modifiers
- history of tuberculosis;
- other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous cell skin cancer, in situ cervical cancer and any other cancer from which patients has been disease-free for 3 years);
- pregnancy or nursing
- psychological, familial, sociological, or geographical factors that would preclude study participation.
- Patients with implantable or wearable electrical devices will be excluded from this study.
- Patients with active tuberculosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
Donald Lam, MD
Phoenix, Arizona, 85032
About this study
Official title: Adjuvant Sequential Intravesical BCG (Bacillus Calmette-Guérin) and Electromotive Mitomycin-C (EMDA/MMC) After Transuretheral Resection (TUR) in Patients With Primary High Risk Non-Muscle Invasive Transitional Cell Carcinoma of the Bladder
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure is disease recurrence rate. Follow up will continue up to 5 years.
For sample size determination, disease recurrence rate will be compared with literature data of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).
Read the detailed description
TURBT (TransUrethral Resection of Bladder Tumor)
Prior to enrolment, all patients must sign a consent form and will have a Complete Blood Count (CBC), Basic Metabolic Panel (BMP) and a Urinalysis (UA) performed. The patients White Blood Count (WBC) must be greater than 4.0 10^9/L and platelet count greater than 150 10^9/L to receive drug.
Week 1, 2, 4, 5, 7 and 8: BCG instillation: 50 mg wet weight (10•2±9•0x108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG are suspended in 50 ml bacteriostatic-free 0.9% Sodium Chloride (NaCl) solution. After bladder draining, the suspension is infused intravesically through a 14 Fr Foley catheter and retained in the bladder for 60-90 min; bladder emptying is followed by catheter removal.
Week 3, 6 and 9: A Foley catheter is inserted and the bladder is carefully drained. 40 mg MMC dissolved in 100 ml NaCl 0.9% solution are instilled intravesically through the electrode catheter by gravity and retained in the bladder for 30 min, while 23 mA for 30 min pulsed electric current is given externally. Two dispersive cathode electrodes are placed on lower abdominal skin after degreasing with alcohol. The bladder is then emptied and the catheter removed. Patients are assigned one course of treatment per week for 6 weeks with sequential BCG and EMDA/MMC. Two BCG instillations and one EMDA/MMC instillation constitute one cycle for a total of two cycles.
A CBC and basic metabolic panel (BMP) will be performed weekly and at the beginning of each cycle. Prior to dosing with mitomycin C at week 3, a CBC will be performed and also at weeks 4 and 5 if the CBC has changed. A UA will be performed prior to each intravesicular instillation.
Maintenance treatment of eMMC will be given at month 3, 4, 6, 7, 9 and 10 (after last dose of BCG of the initial treatment). Maintenance of BCG will be given around month 5, 8, and 11. CBC, BMP, UA, and a history/physical (H\&P) will be performed before each EMDA/MMC procedure. UA and a H\&P will be performed before each BCG.
- Conditions
- Bladder Carcinoma
- Being tested
- Intravesical BCG and EMDA/MMC
- Keywords
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical BCG and EMDA/MMCDevice
Patients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C
| Study group | Role | What they receive |
|---|---|---|
| Intravesical BCG and EMDA/MMC | Experimental | Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC Receives: Device: Intravesical BCG and EMDA/MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess Disease Recurrence Rate
Measured: 5 years
Secondary outcomes (1)
To Compare Complete Response Rates at 3 and 6 Months in Patients With Carcinoma in Situ.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study start24 Feb 2015
- Primary completion11 May 2016
- Study completion11 May 2016
Why it stopped: The institution was requiring extensive changes to the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Shandra Wilson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202044
- Sponsor's protocol ID
- 14-1359.cc
- Status last verified
- May 2019
- First submitted
- 24 Jul 2014
- Last updated
- 14 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Sequential Intravesical BCG (Bacillus Calmette-Guérin) and Electromotive Mitomycin-C (EMDA/MMC) After Transuretheral Resection (TUR) in Patients With Primary High Risk Non-Muscle Invasive Transitional Cell Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT02202044
- Acronym / sponsor ID
- 14-1359.cc
- Conditions
- Bladder Carcinoma
- Keywords
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The institution was requiring extensive changes to the protocol
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 11 May 2016 (actual)
- Study completion
- 11 May 2016 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Posted 14 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure is disease recurrence rate. Follow up will continue up to 5 years.
For sample size determination, disease recurrence rate will be compared with literature data of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).
Detailed description
TURBT (TransUrethral Resection of Bladder Tumor)
Prior to enrolment, all patients must sign a consent form and will have a Complete Blood Count (CBC), Basic Metabolic Panel (BMP) and a Urinalysis (UA) performed. The patients White Blood Count (WBC) must be greater than 4.0 10^9/L and platelet count greater than 150 10^9/L to receive drug.
Week 1, 2, 4, 5, 7 and 8: BCG instillation: 50 mg wet weight (10•2±9•0x108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG are suspended in 50 ml bacteriostatic-free 0.9% Sodium Chloride (NaCl) solution. After bladder draining, the suspension is infused intravesically through a 14 Fr Foley catheter and retained in the bladder for 60-90 min; bladder emptying is followed by catheter removal.
Week 3, 6 and 9: A Foley catheter is inserted and the bladder is carefully drained. 40 mg MMC dissolved in 100 ml NaCl 0.9% solution are instilled intravesically through the electrode catheter by gravity and retained in the bladder for 30 min, while 23 mA for 30 min pulsed electric current is given externally. Two dispersive cathode electrodes are placed on lower abdominal skin after degreasing with alcohol. The bladder is then emptied and the catheter removed. Patients are assigned one course of treatment per week for 6 weeks with sequential BCG and EMDA/MMC. Two BCG instillations and one EMDA/MMC instillation constitute one cycle for a total of two cycles.
A CBC and basic metabolic panel (BMP) will be performed weekly and at the beginning of each cycle. Prior to dosing with mitomycin C at week 3, a CBC will be performed and also at weeks 4 and 5 if the CBC has changed. A UA will be performed prior to each intravesicular instillation.
Maintenance treatment of eMMC will be given at month 3, 4, 6, 7, 9 and 10 (after last dose of BCG of the initial treatment). Maintenance of BCG will be given around month 5, 8, and 11. CBC, BMP, UA, and a history/physical (H\&P) will be performed before each EMDA/MMC procedure. UA and a H\&P will be performed before each BCG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravesical BCG and EMDA/MMC | Experimental | Device: Intravesical BCG and EMDA/MMCPatients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- After a restaging TURBT patients with histologically proven primary high grade (grade3) and/or pT1 transitional cell carcinoma of the bladder, with or without pTis and pTis alone are regarded as being at high risk for tumour recurrence and progression.
- Patients may enroll in this study if they are thought to have no residual disease after TURBT.
- Age 18 years or over
- Adequate bone-marrow reserve- ECOG performance status between 0 and 2
- Patients who are known PPD positive will be screened for active tuberculosis prior to starting treatment with BCG.
Key exclusion criteria (19 listed)
- known allergy to BCG or MMC
- prior systemic infection with BCG
- prior or concomitant urothelial tumours of the upper urinary tract or urethra
- previous muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder
- bladder capacity of less than 200 ml
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 |
|---|---|---|
| Intravesical BCG and EMDA/MMCPatients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C | Device | Intravesical BCG and EMDA/MMC |
Primary outcome
To Assess Disease Recurrence Rate
Time frame: 5 years
1 secondary outcome
To Compare Complete Response Rates at 3 and 6 Months in Patients With Carcinoma in Situ.
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Shandra Wilson, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravesical BCG and EMDA/MMC in people with Bladder Carcinoma, run by University of Colorado, Denver at 2 sites in United States.
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 5 inclusion and 19 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 14 Jun 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess Disease Recurrence Rate (time frame: 5 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 14 Jun 2019.