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Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder (STCC)

Primary Purpose

Bladder Cancer

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Mycobacterium w

BCG (Bacillus Calmette-Guerin)

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring STCC (Superficial Transitional Cell Carcinoma)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCG

Arm Description

Mycobacterium w

bacillus Calmette-Guerin (BCG)

Outcomes

Primary Outcome Measures

Recording of any clinical adverse reactions at anytime during the study for assessment of safety

Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology

Secondary Outcome Measures

Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities

Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period

Full Information

NCT ID

NCT00694915

First Posted

May 29, 2008

Last Updated

August 14, 2021

Sponsor

Cadila Pharnmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00694915

Brief Title

Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder

Acronym

STCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 28, 2008 (Actual)

Primary Completion Date

March 31, 2014 (Actual)

Study Completion Date

October 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cadila Pharnmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

STCC (Superficial Transitional Cell Carcinoma)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Mycobacterium w

Arm Title

BCG

Arm Type

Active Comparator

Arm Description

bacillus Calmette-Guerin (BCG)

Intervention Type

Biological

Intervention Name(s)

Mycobacterium w

Intervention Description

Immunomodulator

Intervention Type

Biological

Intervention Name(s)

BCG (Bacillus Calmette-Guerin)

Other Intervention Name(s)

Bacillus Calmette Guerin

Intervention Description

Immunotherapeutic agent

Primary Outcome Measure Information:

Title

Recording of any clinical adverse reactions at anytime during the study for assessment of safety

Time Frame

24 months

Title

Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities

Time Frame

24 months

Title

Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: