Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder

Study Overview
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Brief Summary
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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.

Official Title
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Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial to Compare the Efficacy and Toxicity of Mycobacterium w Intra-dermal to Intravesical BCG in Patients With Newly Diagnosed Superficial Transitional Cell Carcinoma With High Probability of Recurrence

Conditions
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Bladder Cancer

Intervention / Treatment
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* Biological: Mycobacterium w
* Biological: BCG (Bacillus Calmette-Guerin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and willingness to sign a written informed consent. Patients with newly diagnosed superficial transitional cell carcinoma with completely resected papillary tumors and high probability of recurrence risk i.e. stage T1 Grade 2, T1 Grade 3 & CIS. 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 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 No evidence of residual tumor in the cystoscopy done 6 weeks after the TUR 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: Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study. 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 arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent Previous splenectomy Clinically significant active infection Patients with uncontrolled diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mw<br>Mycobacterium w | Biological: Mycobacterium w<br>* Immunomodulator<br>|
| Active Comparator: BCG<br>bacillus Calmette-Guerin (BCG) | Biological: BCG (Bacillus Calmette-Guerin)<br>* Immunotherapeutic agent<br>* Other names: Bacillus Calmette Guerin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STCC (Superficial Transitional Cell Carcinoma)