- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00694798
Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder (STCC)
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Chandigarh, India
- Post Graduate Institute of Medical Education and Research
-
New Delhi, India
- Dr. Ram Manohar Lohia Hospital & PGIMER
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New Delhi, India
- V. M. Medical College & Safdarjang Hospital
-
-
Gujarat
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Ahmedabad, Gujarat, India
- Aarogyam Speciality Hospital
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Ahmedabad, Gujarat, India
- Gandhi Urocare
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Ahmedabad, Gujarat, India
- Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre
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Rajkot, Gujarat, India
- Urocare Hospital
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Surat, Gujarat, India
- Excel Hospital, Advanced Laproscopy and Urology Centre
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Vadodara, Gujarat, India
- Desai Urological & Maternity Hospital
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Gujrat
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Nadiad, Gujrat, India
- Muljibhai Patel Urological Hospital
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Himachal Pradesh
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Shimla, Himachal Pradesh, India
- Indira Gandhi Medical College
-
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Kerala
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Kochi, Kerala, India
- Lourdes Hospital
-
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Madhya Pradesh
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Indore, Madhya Pradesh, India, 452014
- Choithram Hospital and Research Centre
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Madya Pradesh
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Gwalior, Madya Pradesh, India
- Cancer Hospital and Research Institute
-
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Punjab
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Ludhiana, Punjab, India, 141008
- Christian Medical College
-
-
Rajasthan
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Bikaner, Rajasthan, India
- S.P. Medical College & A. G. of Hospitals
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West Bengal
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Kolkata, West Bengal, India
- IPGMER, S.S.K.M. Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mw
All enrolled patients to receive Mycobacterium w
|
Immunomodulator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response Rate
Time Frame: 15 Months
|
15 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahesh Desai, MD, Muljibhai Patel Urological Hospital
- Principal Investigator: Amillal Bhat, MD, S P Medical College & AG of Hospital
- Principal Investigator: Sushil Bhatia, MD, Choithram Hospital and Research Centre
- Principal Investigator: Kim Mammen, MD, Christian Medical College, Vellore, India
- Principal Investigator: Ketan Rajyaguru, MD, Siddhi Vinayak Hospital
- Principal Investigator: Gaurang Gandhi, MD, Gandhi Urocare
- Principal Investigator: Kapil Thakkar, MD, Excel Hospital
- Principal Investigator: B. R. Shrivastav, MD, Cancer Hospital & Research Institute
- Principal Investigator: Anup Kundu, MD, IPGMER, S.S.K.M. Hospital
- Principal Investigator: Jitendra Amlani, MD, Urocare Hospital
- Principal Investigator: Rasesh Desai, MD, Desai Urological and Maternity Hospital
- Principal Investigator: N. K. Mohanty, MD, V. M. Medical College and Safdarjang hospital
- Principal Investigator: Shrawan K. Singh, MD, Post Graduate Institute of Medical Education and Research
- Principal Investigator: Ketan Shukla, MD, Aarogyam Speciality Hospital
- Principal Investigator: Krishna Moorhty, MD, Lourdes Hospital
- Principal Investigator: Rajeev Sood, MD, Dr. Ram Manohar Lohia Hospital and PGIMER
- Principal Investigator: Purshottam K. Puri, MD, Indira Gandhi Medical College, Shimla
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-80/8230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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