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

August 14, 2021 updated by: Cadila Pharnmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research
      • New Delhi, India, 110001
        • Dr. Ram Manohar Lohia Hospital & PGIMER
      • New Delhi, India, 110029
        • V M Medical College & Safdarjang Hospital
    • Gujarat
      • Rajkot, Gujarat, India, 360002
        • Urocare Hospital
    • Gujrat
      • Nadiad, Gujrat, India
        • Muljibhai Patel Urological Hospital
    • Himachal Pradesh
      • Shimla, Himachal Pradesh, India, 171001
        • Indira Gandhi Medical College
    • Karnataka
      • Bangalore, Karnataka, India, 560090
        • N.R.R. Hospital
      • Manipal, Karnataka, India, 576104
        • Kasturba Medical College and Hospital
    • Kerala
      • Kochi, Kerala, India, 682012
        • Lourdes Hospital
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452014
        • Choithram Hospital and Research Centre
    • Madya Pradesh
      • Gwalior, Madya Pradesh, India, 474009
        • Cancer Hospital and Research Institute
    • Mumbai
      • Parel, Mumbai, India, 400012
        • Seth G S Medical College & K E M Hospital
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College
    • Rajasthan
      • Bikaner, Rajasthan, India, 334003
        • P.B.M. Hospital & A.G. of Hospitals
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • IPGMER, S.S.K.M. Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mw
Mycobacterium w
Biological: Mycobacterium w
Immunomodulator
Active Comparator: BCG
bacillus Calmette-Guerin (BCG)
Biological: BCG (Bacillus Calmette-Guerin)
Immunotherapeutic agent
Other Names:
  • Bacillus Calmette Guerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recording of any clinical adverse reactions at anytime during the study for assessment of safety
Time Frame: 24 months
24 months
Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities
Time Frame: 24 months
24 months
Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period
Time Frame: 15
15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cadila Pharnmaceuticals

Investigators

  • Principal Investigator: Mahesh Desai, MD, Muljibhai Patel Urological Hospital
  • Principal Investigator: Sushil Bhatia, MD, Choithram Hospital and Research Centre
  • Principal Investigator: Kim Mammen, MD, Christian Medical College, Vellore, India
  • Principal Investigator: Jitendra Amlani, MD, Urocare Hospital
  • Principal Investigator: Purshottam K. Puri, MD, Indira Gandhi Medical College, Shimla
  • Principal Investigator: N K Mohanty, MD, V M Medical College & Safdarjang Hospital
  • Principal Investigator: Amillal Bhat, MD, S P Medical College & AG of Hospitals
  • Principal Investigator: Sujata Patwardhan, MD, Seth G S Medical College & K E M Hospital
  • Principal Investigator: B. R. Srivastav, MD, Cancer Hospital and Research Institute
  • Principal Investigator: Anup Kundu, MD, Institute of Post Graduate Medical Education & Research, S. S. K. M. Hospital
  • Principal Investigator: H. K. Moorthy, MD, Lourdes Hospital
  • Principal Investigator: Shrawan K. Singh, MD, Post Graduate Institute of Medical Education & Research
  • Principal Investigator: Rajeev Sood, MD, Dr. Ram Manohar Lohia Hospital & PGIMER
  • Principal Investigator: Padmaraj Hegde, MD, Kasturba Medical College & Hospital
  • Principal Investigator: Yathish Kumar, MD, N.R.R. Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2008

Primary Completion (Actual)

March 31, 2014

Study Completion (Actual)

October 7, 2015

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 14, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-60/9150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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