Bladder CancerPhase 1STCCNCT00694798
Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder
A Phase 1 study testing Mycobacterium w in people with Bladder Cancer, run by Cadila Pharnmaceuticals at 17 sites in India.
Trial summary
The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 17 sitesIndia
- Study dates
- Oct 2008to Jul 2011
- Phase
- Phase 1
- 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
- Informed Consent obtained \& signed:
- Ability to understand and the willingness to sign a written informed consent document.
- Disease characteristics:
- Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ, multiple unresected T1 and Ta high grade.
- BCG-refractory STCC is defined as when there is failure to achieve disease-free state at six months after initiation of BCG therapy either as primary or repeat therapy or recurrence of tumor within three months of completion of adequate induction or maintenance therapy or adequate retreatment. .
- Patient Characteristics:
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- Age: 18 completed years and above Performance status: ECOG 0-2 Life expectancy: At least 24 weeks Hematopoietic:Hemoglobin ≥ 9.0 g/dL
- Co-morbidity
- 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.
- Note: The effects of Investigational product on the developing human fetus 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.
- Intractable urinary tract infection.
- 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.
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- 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.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
- Previous splenectomy
- Clinically significant active infection
- Patients with uncontrolled diabetes mellitus.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
India17 sites
Aarogyam Speciality Hospital
Ahmedabad, Gujarat
Gandhi Urocare
Ahmedabad, Gujarat
Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre
Ahmedabad, Gujarat
S.P. Medical College & A. G. of Hospitals
Bikaner, Rajasthan
Post Graduate Institute of Medical Education and Research
Chandigarh
Cancer Hospital and Research Institute
Gwalior, Madya Pradesh
Choithram Hospital and Research Centre
Indore, Madhya Pradesh, 452014
Lourdes Hospital
Kochi, Kerala
IPGMER, S.S.K.M. Hospital
Kolkata, West Bengal
Christian Medical College
Ludhiana, Punjab, 141008
Muljibhai Patel Urological Hospital
Nadiād, Gujarat
Dr. Ram Manohar Lohia Hospital & PGIMER
New Delhi
V. M. Medical College & Safdarjang Hospital
New Delhi
Urocare Hospital
Rajkot, Gujarat
Indira Gandhi Medical College
Shimla, Himachal Pradesh
Excel Hospital, Advanced Laproscopy and Urology Centre
Surat, Gujarat
Desai Urological & Maternity Hospital
Vadodara, Gujarat
About this study
Official title: Open Label, Single Arm, Exploratory Phase I Clinical Trial to Evaluate Efficacy and Safety of Mycobacterium w (Mw) in BCG Refractory Superficial Transitional Cell Carcinoma
The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety.
- Conditions
- Bladder Cancer
- Being tested
- Mycobacterium w
- Keywords
- STCC, Superficial Transitional Cell Carcinoma- BCG refractor
- 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
| Study group | Role | What they receive |
|---|---|---|
| Mw | Experimental | All enrolled patients to receive Mycobacterium w Receives: Biological: Mycobacterium w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 15 Months
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 startOct 2008
- Primary completionJul 2011
- Study completionJul 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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 HospitalAmillal Bhat, MD, Principal investigator, S P Medical College & AG of HospitalSushil Bhatia, MD, Principal investigator, Choithram Hospital and Research CentreKim Mammen, MD, Principal investigator, Christian Medical College, Vellore, IndiaKetan Rajyaguru, MD, Principal investigator, Siddhi Vinayak HospitalGaurang Gandhi, MD, Principal investigator, Gandhi UrocareKapil Thakkar, MD, Principal investigator, Excel HospitalB. R. Shrivastav, MD, Principal investigator, Cancer Hospital & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694798
- Sponsor's protocol ID
- CR-80/8230
- Acronym
- STCC
- Status last verified
- May 2012
- First submitted
- 3 Jun 2008
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Arm, Exploratory Phase I Clinical Trial to Evaluate Efficacy and Safety of Mycobacterium w (Mw) in BCG Refractory Superficial Transitional Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00694798
- Acronym / sponsor ID
- STCC / CR-80/8230
- Conditions
- Bladder Cancer
- Keywords
- STCC, Superficial Transitional Cell Carcinoma- BCG refractor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (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 primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mw | Experimental | Biological: Mycobacterium wAll enrolled patients to receive Mycobacterium w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Informed Consent obtained \& signed:
- Ability to understand and the willingness to sign a written informed consent document.
- Disease characteristics:
- Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ, multiple unresected T1 and Ta high grade.
- BCG-refractory STCC is defined as when there is failure to achieve disease-free state at six months after initiation of BCG therapy either as primary or repeat therapy or recurrence of tumor within three months of completion of adequate induction or maintenance therapy or adequate retreatment. .
Key exclusion criteria (11 listed)
- Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
- Intractable urinary tract infection.
- 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.
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 |
Primary outcome
Response Rate
Time frame: 15 Months
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 3 May 2012.
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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
Amillal Bhat, MD principal investigator
S P Medical College & AG of Hospital
Sushil Bhatia, MD principal investigator
Choithram Hospital and Research Centre
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mycobacterium w in people with Bladder Cancer, run by Cadila Pharnmaceuticals at 17 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 13 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 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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.
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?
Response Rate (time frame: 15 Months). 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 3 May 2012.