Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mw | Experimental | All enrolled patients to receive Mycobacterium w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycobacterium w | Biological | Immunomodulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 15 Months |
Not provided
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarogyam Speciality Hospital | Ahmedabad | Gujarat | India | |||
| Gandhi Urocare |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C080550 | Mycobacterium w vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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, Chandigarh | 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 | Principal Investigator |
| Ahmedabad |
| Gujarat |
| India |
| Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre | Ahmedabad | Gujarat | India |
| Muljibhai Patel Urological Hospital | Nadiād | Gujarat | India |
| Urocare Hospital | Rajkot | Gujarat | India |
| Excel Hospital, Advanced Laproscopy and Urology Centre | Surat | Gujarat | India |
| Desai Urological & Maternity Hospital | Vadodara | Gujarat | India |
| Indira Gandhi Medical College | Shimla | Himachal Pradesh | India |
| Lourdes Hospital | Kochi | Kerala | India |
| Choithram Hospital and Research Centre | Indore | Madhya Pradesh | 452014 | India |
| Cancer Hospital and Research Institute | Gwalior | Madya Pradesh | India |
| Christian Medical College | Ludhiana | Punjab | 141008 | India |
| S.P. Medical College & A. G. of Hospitals | Bikaner | Rajasthan | India |
| IPGMER, S.S.K.M. Hospital | Kolkata | West Bengal | India |
| Post Graduate Institute of Medical Education and Research | Chandigarh | India |
| Dr. Ram Manohar Lohia Hospital & PGIMER | New Delhi | India |
| V. M. Medical College & Safdarjang Hospital | New Delhi | 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 |