Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder

NCT ID: NCT00694915

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-28
• Study Completion Date: 2015-10-07

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mw

Mycobacterium w

Group Type: EXPERIMENTAL

Mycobacterium w

Intervention Type: BIOLOGICAL

Immunomodulator

BCG

bacillus Calmette-Guerin (BCG)

Group Type: ACTIVE_COMPARATOR

BCG (Bacillus Calmette-Guerin)

Intervention Type: BIOLOGICAL

Immunotherapeutic agent

Interventions

Mycobacterium w

Immunomodulator

Intervention Type: BIOLOGICAL

BCG (Bacillus Calmette-Guerin)

Immunotherapeutic agent

Intervention Type: BIOLOGICAL

Other Intervention Names

Bacillus Calmette Guerin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cadila Pharnmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahesh Desai, MD

Role: PRINCIPAL_INVESTIGATOR

Muljibhai Patel Urological Hospital

N K Mohanty, MD

Role: PRINCIPAL_INVESTIGATOR

V M Medical College & Safdarjang Hospital

Amillal Bhat, MD

Role: PRINCIPAL_INVESTIGATOR

S P Medical College & AG of Hospitals

Sujata Patwardhan, MD

Role: PRINCIPAL_INVESTIGATOR

Seth G S Medical College & K E M Hospital

Kim Mammen, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Sushil Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

Choithram Hospital and Research Centre

B. R. Srivastav, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital and Research Institute

Jitendra Amlani, MD

Role: PRINCIPAL_INVESTIGATOR

Urocare Hospital

Anup Kundu, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Post Graduate Medical Education & Research, S. S. K. M. Hospital

H. K. Moorthy, MD

Role: PRINCIPAL_INVESTIGATOR

Lourdes Hospital

Shrawan K. Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education & Research

Purshottam K. Puri, MD

Role: PRINCIPAL_INVESTIGATOR

Indira Gandhi Medical College, Shimla

Rajeev Sood, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Ram Manohar Lohia Hospital & PGIMER

Padmaraj Hegde, MD

Role: PRINCIPAL_INVESTIGATOR

Kasturba Medical College & Hospital

Yathish Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

N.R.R. Hospital

Locations

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, India

Urocare Hospital

Rajkot, Gujarat, India

Indira Gandhi Medical College

Shimla, Himachal Pradesh, India

N.R.R. Hospital

Bangalore, Karnataka, India

Kasturba Medical college and Hospital

Manipal, Karnataka, India

Lourdes Hospital

Kochi, Kerala, India

Choithram Hospital and Research Centre

Indore, Madhya Pradesh, India

Cancer Hospital and Research Institute

Gwalior, Madya Pradesh, India

Seth G S Medical College & K E M Hospital

Pārel, Mumbai, India

Christian Medical College

Ludhiana, Punjab, India

P.B.M. Hospital & 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

Countries

India

Other Identifiers

CR-60/9150

Identifier Type: -

Identifier Source: org_study_id