Study of Mycobacterium w in BCG refractory Superficial Transitional Cell Carcinoma of Bladder

Phase 1

Completed

Conditions: Health Condition 1: null- BCG refractory Superficial transitional cell carcinoma.Health Condition 2: C679- Malignant neoplasm of bladder, unspecified

Registration Number: CTRI/2009/091/000664

Lead Sponsor: CADILA PHARMACEUTICALS LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

1. Informed Consent obtained & signed:

o Ability to understand and the willingness to sign a written informed consent document.

2. Disease characteristics:

Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ,

multiple unresected T1 and Ta high grade.

Performance status-ECOG 0-2

Life expectancy- -At least 24 weeks

Haemopoetic values -Absolute neutrophil count greater than or equal to 1,500/mm3, Platelet count greater than or equal to 100,000/mm3, Hemoglobin greater than or equal to 9.0 g/dL

Exclusion Criteria

Patients have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study
Pregnant or nursing women
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, diabetes mellitus unstable angina pectoris, hepatic dysfunctions or with evidence of Cirrhosis cardiac arrythemia, or psychiatric illness/social situations that would limit compliance with study requirements
History of hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs or any study reagents
History of splenectomy
Clinically significant active infection
Patients who are immuno-compromised
Patients with eczema

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Response Rate: <br/ ><br>-Time to Tumor Progression <br/ ><br>-Safety <br/ ><br>Timepoint: Response Rate: Tumor will be evaluated after every 3 months by doing sonography, cystoscopy and cytology to find out response rate.

Secondary Outcome Measures

Name	Time	Method
-Time to tumor progression <br/ ><br>-SafetyTimepoint: Time to Tumor Progression: Time to tumor progression will be evaluated every 3 months for 15 months during the study period. <br/ ><br>Safety: Safety will be evaluated by the various side effects patient comes across while on study drug. <br/ ><br>