Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder

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

Interventions

BIOLOGICAL

Mycobacterium w

Immunomodulator

BIOLOGICAL

BCG (Bacillus Calmette-Guerin)

Immunotherapeutic agent

Sponsors & Collaborators

• Cadila Pharnmaceuticals

  lead INDUSTRY

Principal Investigators

• Mahesh Desai, MD · Muljibhai Patel Urological Hospital

• N K Mohanty, MD · V M Medical College & Safdarjang Hospital

• Amillal Bhat, MD · S P Medical College & AG of Hospitals

• Sujata Patwardhan, MD · Seth G S Medical College & K E M Hospital

• Kim Mammen, MD · Christian Medical College, Vellore, India

• Sushil Bhatia, MD · Choithram Hospital and Research Centre

• B. R. Srivastav, MD · Cancer Hospital and Research Institute

• Jitendra Amlani, MD · Urocare Hospital

• Anup Kundu, MD · Institute of Post Graduate Medical Education & Research, S. S. K. M. Hospital

• H. K. Moorthy, MD · Lourdes Hospital

• Shrawan K. Singh, MD · Post Graduate Institute of Medical Education & Research

• Purshottam K. Puri, MD · Indira Gandhi Medical College, Shimla

• Rajeev Sood, MD · Dr. Ram Manohar Lohia Hospital & PGIMER

• Padmaraj Hegde, MD · Kasturba Medical College & Hospital

• Yathish Kumar, MD · N.R.R. Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-28

Primary Completion

2014-03-31

Completion

2015-10-07

Countries

• India

Study Locations