Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder

NCT00694798 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-05-03

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety.

Conditions

Interventions

BIOLOGICAL

Mycobacterium w

Immunomodulator

Sponsors & Collaborators

  • Cadila Pharnmaceuticals

    lead INDUSTRY

Principal Investigators

  • Mahesh Desai, MD · Muljibhai Patel Urological Hospital

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

  • Sushil Bhatia, MD · Choithram Hospital and Research Centre

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

  • Ketan Rajyaguru, MD · Siddhi Vinayak Hospital

  • Gaurang Gandhi, MD · Gandhi Urocare

  • Kapil Thakkar, MD · Excel Hospital

  • B. R. Shrivastav, MD · Cancer Hospital & Research Institute

  • Anup Kundu, MD · IPGMER, S.S.K.M. Hospital

  • Jitendra Amlani, MD · Urocare Hospital

  • Rasesh Desai, MD · Desai Urological and Maternity Hospital

  • N. K. Mohanty, MD · V. M. Medical College and Safdarjang hospital

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

  • Ketan Shukla, MD · Aarogyam Speciality Hospital

  • Krishna Moorhty, MD · Lourdes hospital

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

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00694798 on ClinicalTrials.gov