Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder (STCC)
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ClinicalTrials.gov Identifier: NCT00694798 |
Recruitment Status :
Completed
First Posted : June 11, 2008
Last Update Posted : May 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bladder Cancer | Biological: Mycobacterium w | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Mw
All enrolled patients to receive Mycobacterium w
|
Biological: Mycobacterium w
Immunomodulator |
- Response Rate [ Time Frame: 15 Months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694798

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 |
Responsible Party: | Cadila Pharnmaceuticals |
ClinicalTrials.gov Identifier: | NCT00694798 |
Other Study ID Numbers: |
CR-80/8230 |
First Posted: | June 11, 2008 Key Record Dates |
Last Update Posted: | May 3, 2012 |
Last Verified: | May 2012 |
STCC Superficial Transitional Cell Carcinoma- BCG refractor |
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |