Carcinoma of Urinary Bladder, SuperficialPhase 2/3NCT00330707
Combined Use of BCG and Interferon Alpha in Bladder Cancer
A Phase 2/3 study testing Bacillus Calmette Guerin and interferon alpha in people with Carcinoma of Urinary Bladder, Superficial, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
To compare the toxicity and efficacy of the combination of BCG and interferon alpha to standard dose and low dose BCG alone in high risk superficial bladder cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma of Urinary Bladder, Superficial
- What is being tested?
- Bacillus Calmette Guerin and interferon alpha
- How many people
- 140 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 1995to Jun 2005
- 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 must have completely resected, histologically?proven urothelial carcinoma of the urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/or carcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patients with Stage Ta urothelial carcinoma must be judged to be at increased risk of tumor recurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeks prior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade III urothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia or carcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection. "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients who have received prior intravesical therapy other than BCG were eligible provided they had not undergone a course of any other intravesical agent within two months prior to entry. (4) There was no age restriction; however, all patients registered had to be willing to be available for 5?year follow up and to have a life expectancy of at least two years. (5) Patients had a Karnofsky score >50. (6) Women of child?bearing age were using effective contraceptive methods. (7) Patients agreed not to take vitamin supplements (except for those prescribed in the study) for the duration of the trial. (8) Pretreatment laboratory tests and radiological examinations must have been obtained during the 16 weeks prior to patient registration. (9) All patients had to be informed of the investigational nature of this study, and had to sign a written informed consent in accordance with institutional guidelines.
Who cannot join
- (1) Patients with medical illness or mental status, which would preclude cooperation with the study. (2) Patients who were immunodeficient, or had received immunosuppressive radiation therapy or chemotherapy. (3) Patients with urothelial carcinoma of stage T2 or higher. (4) Patients who had evidence of urothelial carcinoma of the upper urinary tract at the time of recruitment. (5) Patients who had received radiation therapy for bladder cancer within one year prior to registration. (6) Patients who had been previously treated with intravesical BCG. (7) Patients with active tuberculosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre Randomised Controlled Double-blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer
To compare the toxicity and efficacy of the combination of BCG and interferon alpha to standard dose and low dose BCG alone in high risk superficial bladder cancer
Read the detailed description
140 eligible patients with high risk superifical bladder cancer would be randomised to receive standard dose BCG, low dose BCG or the combination of low dose BCG and interferon alpha in a schedule of "6+3" weekly intravesical instillations. Patients would be closely monitored with cystoscopy and urine cytology and intravenous urograms when indicated. Pre-and post-instillation urine samples would be collected for cytokine analysis.
- Being tested
- Bacillus Calmette Guerin and interferon alpha
- Keywords
- bladder cancer, BCG, interferon alpha
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus Calmette Guerin and interferon alphaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
local toxicity
systemic toxicity
recurrence rate
progression rate
disease-specific mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startOct 1995
- Study completionJun 2005
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 Carcinoma of Urinary Bladder, SuperficialStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Investigators
- Kesavan Esuvaranathan, FRCSEd MD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330707
- Sponsor's protocol ID
- NMRC/0085/1995
- Status last verified
- Mar 2011
- First submitted
- 26 May 2006
- Last updated
- 4 Mar 2011
- Results posted
- No
Publications
Chiong E, Kesavan A, Mahendran R, Chan YH, Sng JH, Lim YK, Kamaraj R, Tan TM, Esuvaranathan K. NRAMP1 and hGPX1 gene polymorphism and response to bacillus Calmette-Guerin therapy for bladder cancer. Eur Urol. 2011 Mar;59(3):430-7. doi: 10.1016/j.eururo.2010.11.031. Epub 2010 Dec 1.
PubMed 21163569
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomised Controlled Double-blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT00330707
- Acronym / sponsor ID
- NMRC/0085/1995
- Keywords
- bladder cancer, BCG, interferon alpha
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Oct 1995
- Study completion
- Jun 2005
- First posted
- 29 May 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.
To compare the toxicity and efficacy of the combination of BCG and interferon alpha to standard dose and low dose BCG alone in high risk superficial bladder cancer
Detailed description
140 eligible patients with high risk superifical bladder cancer would be randomised to receive standard dose BCG, low dose BCG or the combination of low dose BCG and interferon alpha in a schedule of "6+3" weekly intravesical instillations. Patients would be closely monitored with cystoscopy and urine cytology and intravenous urograms when indicated. Pre-and post-instillation urine samples would be collected for cytokine analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have completely resected, histologically?proven urothelial carcinoma of the urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/or carcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patients with Stage Ta urothelial carcinoma must be judged to be at increased risk of tumor recurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeks prior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade III urothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia or carcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection. "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients who have received prior intravesical therapy other than BCG were eligible provided they had not undergone a course of any other intravesical agent within two months prior to entry. (4) There was no age restriction; however, all patients registered had to be willing to be available for 5?year follow up and to have a life expectancy of at least two years. (5) Patients had a Karnofsky score >50. (6) Women of child?bearing age were using effective contraceptive methods. (7) Patients agreed not to take vitamin supplements (except for those prescribed in the study) for the duration of the trial. (8) Pretreatment laboratory tests and radiological examinations must have been obtained during the 16 weeks prior to patient registration. (9) All patients had to be informed of the investigational nature of this study, and had to sign a written informed consent in accordance with institutional guidelines.
Key exclusion criteria (1 listed)
- (1) Patients with medical illness or mental status, which would preclude cooperation with the study. (2) Patients who were immunodeficient, or had received immunosuppressive radiation therapy or chemotherapy. (3) Patients with urothelial carcinoma of stage T2 or higher. (4) Patients who had evidence of urothelial carcinoma of the upper urinary tract at the time of recruitment. (5) Patients who had received radiation therapy for bladder cancer within one year prior to registration. (6) Patients who had been previously treated with intravesical BCG. (7) Patients with active tuberculosis.
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 |
|---|---|---|
| Bacillus Calmette Guerin and interferon alpha | Drug | – |
Primary outcome
local toxicity
systemic toxicity
recurrence rate
progression rate
disease-specific mortality
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 4 Mar 2011.
- Derived from this study: PubMed 21163569Chiong E, Kesavan A, Mahendran R, Chan YH, Sng JH, Lim YK, Kamaraj R, Tan TM, Esuvaranathan K. NRAMP1 and hGPX1 gene polymorphism and response to bacillus Calmette-Guerin therapy for bladder cancer. Eur Urol. 2011 Mar;59(3):430-7. doi: 10.1016/j.eururo.2010.11.031. Epub 2010 Dec 1.
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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.
Kesavan Esuvaranathan, FRCSEd MD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bacillus Calmette Guerin and interferon alpha in people with Carcinoma of Urinary Bladder, Superficial, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 1 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 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
local toxicity. The study lists 5 primary outcomes in all. 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 NCT00330707, 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 4 Mar 2011.