Bladder CancerPhase 2STCCNCT00694915
Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder
A Phase 2 study testing Mycobacterium w and BCG (Bacillus Calmette-Guerin) in people with Bladder Cancer, run by Cadila Pharnmaceuticals at 15 sites in India.
Trial summary
The purpose of this study is to determine and compare the effect of this treatment on recurrence rate and to assess the toxicity in both arms of patients with STCC. Other objectives include determining the effects of this treatment on quality of life, and comparing the effect of Mycobacterium w on time to tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Mycobacterium w and BCG (Bacillus Calmette-Guerin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 15 sitesIndia
- Study dates
- 28 Aug 2008to 7 Oct 2015
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent.
- Patients with newly diagnosed superficial transitional cell carcinoma with completely resected papillary tumors and high probability of recurrence risk i.e. stage T1 Grade 2, T1 Grade 3 \& CIS.
- and Ta or T1 disease with an increased risk of recurrence defined as 2 tumors (primary and recurrent or 2 recurrences) within 1 year, 3 or more within the last 6 months and/ or carcinoma in situ on at least one random biopsy.
- 18 years or above
- ECOG of 0-2 range
- life expectancy is at least 24 weeks.
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- Absolute neutrophil count≥1,500/c.mm
- platelet count≥100,000//c.mm
- Hemoglobin ≥9.0g/dL
- No patient who has eczema will be allowed to participate in this study.
- Patients who are immuno-compromised will not be enrolled.
- Patients with severe hepatic dysfunctions or with evidence of Cirrhosis will not be enrolled.
- Patients with uncontrolled diabetes mellitus will not be enrolled in the study
- No evidence of residual tumor in the cystoscopy done 6 weeks after the TUR
- Note: The effects of Investigational product on the developing human fetus is at the recommended therapeutic dose are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
- No patient who has eczema should be allowed to participate in this study.
- Patients who are immuno-compromised should not be enrolled.
- Patients with severe hepatic dysfunctions or evidence of Cirrhosis should not be enrolled.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
- Pregnant women or nursing women are excluded from this study because agents used in the study have potential for teratogenic or abortifacient effects. Because there is known potential risk for adverse events in nursing infants secondary to treatment of the mother with investigational agent, breastfeeding should be discontinued if the mother is treated with investigational product.
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent
- Previous splenectomy
- Clinically significant active infection
- Patients with uncontrolled diabetes mellitus.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
India15 sites
N.R.R. Hospital
Bangalore, Karnataka, 560090
P.B.M. Hospital & A.G. of Hospitals
Bikaner, Rajasthan, 334003
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Cancer Hospital and Research Institute
Gwalior, Madya Pradesh, 474009
Choithram Hospital and Research Centre
Indore, Madhya Pradesh, 452014
Lourdes Hospital
Kochi, Kerala, 682012
IPGMER, S.S.K.M. Hospital
Kolkata, West Bengal, 700020
Christian Medical College
Ludhiana, Punjab, 141008
Kasturba Medical college and Hospital
Manipal, Karnataka, 576104
Muljibhai Patel Urological Hospital
Nadiād, Gujarat
Dr. Ram Manohar Lohia Hospital & PGIMER
New Delhi, 110001
V M Medical College & Safdarjang Hospital
New Delhi, 110029
Seth G S Medical College & K E M Hospital
Parel, Mumbai, 400012
Urocare Hospital
Rajkot, Gujarat, 360002
Indira Gandhi Medical College
Shimla, Himachal Pradesh, 171001
About this study
Official title: Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial to Compare the Efficacy and Toxicity of Mycobacterium w Intra-dermal to Intravesical BCG in Patients With Newly Diagnosed Superficial Transitional Cell Carcinoma With High Probability of Recurrence
The purpose of this study is to determine and compare the effect of this treatment on recurrence rate and to assess the toxicity in both arms of patients with STCC. Other objectives include determining the effects of this treatment on quality of life, and comparing the effect of Mycobacterium w on time to tumor progression.
- Conditions
- Bladder Cancer
- Being tested
- Mycobacterium w, BCG (Bacillus Calmette-Guerin)
- Keywords
- STCC (Superficial Transitional Cell Carcinoma)
- 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.
Mycobacterium wBiological
Immunomodulator
BCG (Bacillus Calmette-Guerin)Biological
Also called Bacillus Calmette Guerin
Immunotherapeutic agent
| Study group | Role | What they receive |
|---|---|---|
| Mw | Experimental | Mycobacterium w Receives: Biological: Mycobacterium w |
| BCG | Active comparator | bacillus Calmette-Guerin (BCG) Receives: Biological: BCG (Bacillus Calmette-Guerin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of any clinical adverse reactions at anytime during the study for assessment of safety
Measured: 24 months
Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology
Measured: 24 months
Secondary outcomes (2)
Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities
Measured: 24 months
Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period
Measured: 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study start28 Aug 2008
- Primary completion31 Mar 2014
- Study completion7 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahesh Desai, MD, Principal investigator, Muljibhai Patel Urological HospitalN K Mohanty, MD, Principal investigator, V M Medical College & Safdarjang HospitalAmillal Bhat, MD, Principal investigator, S P Medical College & AG of HospitalsSujata Patwardhan, MD, Principal investigator, Seth G S Medical College & K E M HospitalKim Mammen, MD, Principal investigator, Christian Medical College, Vellore, IndiaSushil Bhatia, MD, Principal investigator, Choithram Hospital and Research CentreB. R. Srivastav, MD, Principal investigator, Cancer Hospital and Research InstituteJitendra Amlani, MD, Principal investigator, Urocare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694915
- Sponsor's protocol ID
- CR-60/9150
- Acronym
- STCC
- Status last verified
- Aug 2021
- First submitted
- 29 May 2008
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial to Compare the Efficacy and Toxicity of Mycobacterium w Intra-dermal to Intravesical BCG in Patients With Newly Diagnosed Superficial Transitional Cell Carcinoma With High Probability of Recurrence
- ClinicalTrials.gov ID
- NCT00694915
- Acronym / sponsor ID
- STCC / CR-60/9150
- Conditions
- Bladder Cancer
- Keywords
- STCC (Superficial Transitional Cell Carcinoma)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2008 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 7 Oct 2015 (actual)
- First posted
- 11 Jun 2008 (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 and compare the effect of this treatment on recurrence rate and to assess the toxicity in both arms of patients with STCC. Other objectives include determining the effects of this treatment on quality of life, and comparing the effect of Mycobacterium w on time to tumor progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mw | Experimental | Biological: Mycobacterium wMycobacterium w |
| BCG | Active comparator | Biological: BCG (Bacillus Calmette-Guerin)bacillus Calmette-Guerin (BCG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability to understand and willingness to sign a written informed consent.
- Patients with newly diagnosed superficial transitional cell carcinoma with completely resected papillary tumors and high probability of recurrence risk i.e. stage T1 Grade 2, T1 Grade 3 \& CIS.
- and Ta or T1 disease with an increased risk of recurrence defined as 2 tumors (primary and recurrent or 2 recurrences) within 1 year, 3 or more within the last 6 months and/ or carcinoma in situ on at least one random biopsy.
- 18 years or above
- ECOG of 0-2 range
Key exclusion criteria (11 listed)
- Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
- No patient who has eczema should be allowed to participate in this study.
- Patients who are immuno-compromised should not be enrolled.
- Patients with severe hepatic dysfunctions or evidence of Cirrhosis should not be enrolled.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
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 |
|---|---|---|
| Mycobacterium wImmunomodulator | Biological | Mw |
| BCG (Bacillus Calmette-Guerin)Also: Bacillus Calmette GuerinImmunotherapeutic agent | Biological | BCG |
Primary outcome
Recording of any clinical adverse reactions at anytime during the study for assessment of safety
Time frame: 24 months
Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology
Time frame: 24 months
2 secondary outcomes
Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities
Time frame: 24 months
Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period
Time frame: 15
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 17 Aug 2021.
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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.
Mahesh Desai, MD principal investigator
Muljibhai Patel Urological Hospital
N K Mohanty, MD principal investigator
V M Medical College & Safdarjang Hospital
Amillal Bhat, MD principal investigator
S P Medical College & AG of Hospitals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycobacterium w and BCG (Bacillus Calmette-Guerin) in people with Bladder Cancer, run by Cadila Pharnmaceuticals at 15 sites in India.
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 15 inclusion and 11 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in India. 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 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?
Recording of any clinical adverse reactions at anytime during the study for assessment of safety (time frame: 24 months). The study lists 2 primary outcomes in all. 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 17 Aug 2021.