Bladder NeoplasmsPhase 2/3NCT00406068
Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
A Phase 2/3 study testing Mycobacterial cell wall-DNA complex in people with Bladder Neoplasms, run by Bioniche Life Sciences Inc. at 31 sites in 2 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Neoplasms
- What is being tested?
- Mycobacterial cell wall-DNA complex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Nov 2006to Jul 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients refractory to BCG therapy;
- Patients with histologically confirmed diagnosis of high grade lesions;
- Diagnosis of high grade lesion must be within 56 days prior to beginning of study treatment;
- Have had all visible papillary lesion(s) resected by TURBT within 56 days prior to beginning of study treatment;
- Available for the whole duration of the study including follow-up (60 months);
- Life expectancy of > 5 years;
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- Patients with an ECOG performance status grade of 2 or less;
- Absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from beginning of study treatment;
- Able to understand and give written informed consent;
- In the investigator's judgment, the patient is able to participate in the study.
Who cannot join
- Current or previous history of muscle invasive tumors;
- Current or previous history of lymph node or distant metastases from bladder cancer;
- Current systemic cancer therapy;
- Current or prior pelvic external beam radiotherapy;
- Pelvic brachytherapy within 2 years of study entry;
- Prior treatment with MCC;
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- Patients with existing urinary tract infection or recurrent severe bacterial cystitis;
- Clinically significant and unexplained elevations of liver or renal function tests;
- White blood cell count below 3 x109/L (3,000/mm3) or platelet count below 100 x 109/L(100,000/mm3);
- Severe cardiovascular disease;
- Women who are pregnant or lactating;
- Congenital or acquired immune deficiency;
- With history of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, stage T1 prostate cancer, carcinoma in situ of the cervix or colon polyps);
- Previous investigational treatment within 3 months from beginning of study treatment;
- Patients who cannot hold the instillation for one hour;
- Patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy);
- Clinically significant active infections;
- Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States20 sites
Johns Hopkins University
Baltimore, Maryland, 21231
The University of Chicago Hospitals
Chicago, Illinois, 60637
Urology Clinics of North Texas, P.A.
Dallas, Texas, 75231
Welborn Clinic
Evansville, Indiana, 47713
M.D. Anderson Cancer Center
Houston, Texas, 77030
Sheldon J Freedman, MD, Ltd
Las Vegas, Nevada, 89148
University of Miami School of Medicine
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, 06052
Memorial Sloan Kettering Cancer Centre
New York, New York, 10021
Sentara Medical Group - Urology of Virginia, PC
Norfolk, Virginia, 23502
Winter Park Urology Associates P.A.
Orlando, Florida, 32803
BCG Oncology
Phoenix, Arizona, 85032
Triangle Urology Group
Pittsburgh, Pennsylvania, 15212
Hudson Valley Urology
Poughkeepsie, New York, 12601
University of Rochester Medical Center
Rochester, New York, 14642
Urology San Antonio Research, PA
San Antonio, Texas, 78229
San Diego Clinical Trials
San Diego, California, 92120
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Delaware Valley Urology, LLC-Voorhees
Voorhees Township, New Jersey, 08043
Canada11 sites
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7
London Health Sciences Centre
London, Ontario, N6A 5W9
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3J4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Centre de Recherche du CHUQ
Québec, Quebec, G1R 2J6
Andreou Research
Surrey, British Columbia, V3V 1N1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network / Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
The Male Health Center
Toronto, Ontario, M6A 3B5
Can-Med Clinical Research
Victoria, British Columbia, V8T 5G1
Dr. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
About this study
Official title: Open-label, Multi-center Study of the Efficacy and Safety of MCC in the Treatment of Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and Who Are Refractory to BCG
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).
Read the detailed description
The study will be divided into 3 phases: Induction, Maintenance, and Follow-up.
The Induction Phase will cover a period of 6 weeks. During this time, patients will receive 6 weekly intravesical instillations of 8 mg MCC. The patients will be evaluated at month 3, at which time the patients will enter the Maintenance Phase. The Maintenance Phase will last from month 3 to month 24, and during this time, patients will receive weekly MCC instillations for three weeks at months 3, 6, 12, 18, and 24 and evaluations will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24.
At month 3, the patient will be evaluated to assure that the disease is not progressing. Cytology, cystoscopy and biopsies will be performed to obtain adequate staging (if residual tumor persists). If the patient is disease-free, maintenance therapy will be initiated. Patients with non-muscle invasive tumors at month 3 will, at the discretion of the investigator, receive either a second 6-week induction course or a 3-week maintenance course. Patients who show progression to muscle invasive disease will be referred to other treatments.
At month 6 and thereafter at each evaluation visit, patients will be evaluated and managed according to the following results:
- Patients who are disease-free will continue on maintenance treatment.
- Patients who are not disease-free (evidence of papillary lesions, CIS or muscle invasive disease) will be withdrawn from further study treatment and will be referred to other therapies at the discretion of the investigator.
The final 36 months of the study is the Follow-up Phase. Evaluations will be performed at months 30, 36, 42, 48, 54 and 60.
Efficacy evaluations will include standard cystoscopy, biopsies and urine cytology. During the Maintenance Phase, standard cystoscopies will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24 for the surveillance of bladder tumors. During the months that instillations will be performed, cystoscopies will be conducted only once at each of these months. During the Follow-up Phase, cystoscopies will be performed at months 30, 36, 42, 48, 54 and 60.
Mandatory bladder biopsies will be done for all patients at month 6.
During the course of the study, biopsies will be taken only if evident or suspicious lesions are seen during cystoscopy or in case of negative cystoscopy but positive cytology.
- Conditions
- Bladder Neoplasms
- Being tested
- Mycobacterial cell wall-DNA complex
- Keywords
- Bladder neoplasm, Intravesical drug administration, Neoplasm recurrence, local, Transitional cell, carcinoma, Carcinoma in situ, Mycobacterium
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasm Recurrence, Local, Carcinoma, Transitional Cell, Carcinoma in Situ, Mycobacterium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycobacterial cell wall-DNA complexDrug
Also called MCC - Urocidin
8 mg MCC, intravesical - Induction Phase (6 weekly intravesical instillations) and Maintenance Phase (3 weekly instillations at months 3, 6, 12, 18 and 24).
| Study group | Role | What they receive |
|---|---|---|
| Mycobacterial cell wall-DNA complex | Experimental | Mycobacterial cell wall-DNA complex Receives: Drug: Mycobacterial cell wall-DNA complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year disease-free survival rate
Measured: Prospective
Secondary outcomes (5)
The 3, 6 and 24 month disease-free survival rate
Measured: Prospective
Duration of disease-free survival in all patients
Measured: Prospective
Time to progression to muscle invasive disease
Measured: Prospective
Overall survival in all patients
Measured: Prospective
Rate of overall drug-related adverse events leading to two consecutive treatment delays of one week each or to the discontinuation of treatment.
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2011
- Study completionJul 2011
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 Bladder NeoplasmsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioniche Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alvaro Morales, MD, Principal investigator, Centre for Applied Urological Research, Kingston General Hospital/Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406068
- Sponsor's protocol ID
- HIS-0611-0602
- Status last verified
- Jul 2016
- First submitted
- 1 Dec 2006
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morales A, Herr H, Steinberg G, Given R, Cohen Z, Amrhein J, Kamat AM. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus Calmette-Guerin. J Urol. 2015 Apr;193(4):1135-43. doi: 10.1016/j.juro.2014.09.109. Epub 2014 Oct 5.
PubMed 25286009
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-center Study of the Efficacy and Safety of MCC in the Treatment of Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and Who Are Refractory to BCG
- ClinicalTrials.gov ID
- NCT00406068
- Acronym / sponsor ID
- HIS-0611-0602
- Conditions
- Bladder Neoplasms
- Keywords
- Bladder neoplasm, Intravesical drug administration, Neoplasm recurrence, local, Transitional cell, carcinoma, Carcinoma in situ, Mycobacterium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Bioniche Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Dec 2006 (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 purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).
Detailed description
The study will be divided into 3 phases: Induction, Maintenance, and Follow-up.
The Induction Phase will cover a period of 6 weeks. During this time, patients will receive 6 weekly intravesical instillations of 8 mg MCC. The patients will be evaluated at month 3, at which time the patients will enter the Maintenance Phase. The Maintenance Phase will last from month 3 to month 24, and during this time, patients will receive weekly MCC instillations for three weeks at months 3, 6, 12, 18, and 24 and evaluations will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24.
At month 3, the patient will be evaluated to assure that the disease is not progressing. Cytology, cystoscopy and biopsies will be performed to obtain adequate staging (if residual tumor persists). If the patient is disease-free, maintenance therapy will be initiated. Patients with non-muscle invasive tumors at month 3 will, at the discretion of the investigator, receive either a second 6-week induction course or a 3-week maintenance course. Patients who show progression to muscle invasive disease will be referred to other treatments.
At month 6 and thereafter at each evaluation visit, patients will be evaluated and managed according to the following results:
- Patients who are disease-free will continue on maintenance treatment.
- Patients who are not disease-free (evidence of papillary lesions, CIS or muscle invasive disease) will be withdrawn from further study treatment and will be referred to other therapies at the discretion of the investigator.
The final 36 months of the study is the Follow-up Phase. Evaluations will be performed at months 30, 36, 42, 48, 54 and 60.
Efficacy evaluations will include standard cystoscopy, biopsies and urine cytology. During the Maintenance Phase, standard cystoscopies will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24 for the surveillance of bladder tumors. During the months that instillations will be performed, cystoscopies will be conducted only once at each of these months. During the Follow-up Phase, cystoscopies will be performed at months 30, 36, 42, 48, 54 and 60.
Mandatory bladder biopsies will be done for all patients at month 6.
During the course of the study, biopsies will be taken only if evident or suspicious lesions are seen during cystoscopy or in case of negative cystoscopy but positive cytology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mycobacterial cell wall-DNA complex | Experimental | Drug: Mycobacterial cell wall-DNA complexMycobacterial cell wall-DNA complex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients refractory to BCG therapy;
- Patients with histologically confirmed diagnosis of high grade lesions;
- Diagnosis of high grade lesion must be within 56 days prior to beginning of study treatment;
- Have had all visible papillary lesion(s) resected by TURBT within 56 days prior to beginning of study treatment;
- Available for the whole duration of the study including follow-up (60 months);
Key exclusion criteria (18 listed)
- Current or previous history of muscle invasive tumors;
- Current or previous history of lymph node or distant metastases from bladder cancer;
- Current systemic cancer therapy;
- Current or prior pelvic external beam radiotherapy;
- Pelvic brachytherapy within 2 years of study entry;
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 |
|---|---|---|
| Mycobacterial cell wall-DNA complexAlso: MCC - Urocidin8 mg MCC, intravesical - Induction Phase (6 weekly intravesical instillations) and Maintenance Phase (3 weekly instillations at months 3, 6, 12, 18 and 24). | Drug | Mycobacterial cell wall-DNA complex |
Primary outcome
One year disease-free survival rate
Time frame: Prospective
5 secondary outcomes
The 3, 6 and 24 month disease-free survival rate
Time frame: Prospective
Duration of disease-free survival in all patients
Time frame: Prospective
Time to progression to muscle invasive disease
Time frame: Prospective
Overall survival in all patients
Time frame: Prospective
Rate of overall drug-related adverse events leading to two consecutive treatment delays of one week each or to the discontinuation of treatment.
Time frame: Prospective
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 28 Jul 2016.
- Results publication: PubMed 25286009Morales A, Herr H, Steinberg G, Given R, Cohen Z, Amrhein J, Kamat AM. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus Calmette-Guerin. J Urol. 2015 Apr;193(4):1135-43. doi: 10.1016/j.juro.2014.09.109. Epub 2014 Oct 5.
- Publication that includes results for this study.Link provided by the sponsor.
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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.
Alvaro Morales, MD principal investigator
Centre for Applied Urological Research, Kingston General Hospital/Queen's University
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mycobacterial cell wall-DNA complex in people with Bladder Neoplasms, run by Bioniche Life Sciences Inc. at 31 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 10 inclusion and 18 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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
One year disease-free survival rate (time frame: Prospective). 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 NCT00406068, 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 28 Jul 2016.