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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mw | Experimental | Mycobacterium w |
|
| BCG | Active Comparator | bacillus Calmette-Guerin (BCG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycobacterium w | Biological | Immunomodulator |
| |
| BCG (Bacillus Calmette-Guerin) |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of any clinical adverse reactions at anytime during the study for assessment of safety | 24 months | |
| Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities | 24 months | |
| Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period | 15 |
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Inclusion Criteria:
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.
Absolute neutrophil count≥1,500/c.mm
platelet count≥100,000//c.mm
Hemoglobin ≥9.0g/dL
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahesh Desai, MD | Muljibhai Patel Urological Hospital | Principal Investigator |
| N K Mohanty, MD | V M Medical College & Safdarjang Hospital | Principal Investigator |
| Amillal Bhat, MD | S P Medical College & AG of Hospitals | Principal Investigator |
| Sujata Patwardhan, MD | Seth G S Medical College & K E M Hospital | Principal Investigator |
| Kim Mammen, MD | Christian Medical College, Vellore, India | Principal Investigator |
| Sushil Bhatia, MD | Choithram Hospital and Research Centre | Principal Investigator |
| B. R. Srivastav, MD | Cancer Hospital and Research Institute | Principal Investigator |
| Jitendra Amlani, MD | Urocare Hospital | Principal Investigator |
| Anup Kundu, MD | Institute of Post Graduate Medical Education & Research, S. S. K. M. Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muljibhai Patel Urological Hospital | Nadiād | Gujarat | India | |||
| Urocare Hospital |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C080550 | Mycobacterium w vaccine |
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Biological |
Immunotherapeutic agent |
|
|
| H. K. Moorthy, MD | Lourdes Hospital | Principal Investigator |
| Shrawan K. Singh, MD | Post Graduate Institute of Medical Education & Research | Principal Investigator |
| Purshottam K. Puri, MD | Indira Gandhi Medical College, Shimla | Principal Investigator |
| Rajeev Sood, MD | Dr. Ram Manohar Lohia Hospital & PGIMER | Principal Investigator |
| Padmaraj Hegde, MD | Kasturba Medical College & Hospital | Principal Investigator |
| Yathish Kumar, MD | N.R.R. Hospital | Principal Investigator |
| Rajkot |
| Gujarat |
| 360002 |
| India |
| Indira Gandhi Medical College | Shimla | Himachal Pradesh | 171001 | India |
| N.R.R. Hospital | Bangalore | Karnataka | 560090 | India |
| Kasturba Medical college and Hospital | Manipal | Karnataka | 576104 | India |
| Lourdes Hospital | Kochi | Kerala | 682012 | India |
| Choithram Hospital and Research Centre | Indore | Madhya Pradesh | 452014 | India |
| Cancer Hospital and Research Institute | Gwalior | Madya Pradesh | 474009 | India |
| Seth G S Medical College & K E M Hospital | Pārel | Mumbai | 400012 | India |
| Christian Medical College | Ludhiana | Punjab | 141008 | India |
| P.B.M. Hospital & A.G. of Hospitals | Bikaner | Rajasthan | 334003 | India |
| IPGMER, S.S.K.M. Hospital | Kolkata | West Bengal | 700020 | India |
| Post Graduate Institute of Medical Education and Research | Chandigarh | 160012 | India |
| Dr. Ram Manohar Lohia Hospital & PGIMER | New Delhi | 110001 | India |
| V M Medical College & Safdarjang Hospital | New Delhi | 110029 | India |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D045424 |
| Complex Mixtures |