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

May 2, 2012 updated by: Cadila Pharnmaceuticals

Open Label, Single Arm, Exploratory Phase I Clinical Trial to Evaluate Efficacy and Safety of Mycobacterium w (Mw) in BCG Refractory Superficial Transitional Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

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

      • Chandigarh, India
        • Post Graduate Institute of Medical Education and Research
      • New Delhi, India
        • Dr. Ram Manohar Lohia Hospital & PGIMER
      • New Delhi, India
        • V. M. Medical College & Safdarjang Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Aarogyam Speciality Hospital
      • Ahmedabad, Gujarat, India
        • Gandhi Urocare
      • Ahmedabad, Gujarat, India
        • Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre
      • Rajkot, Gujarat, India
        • Urocare Hospital
      • Surat, Gujarat, India
        • Excel Hospital, Advanced Laproscopy and Urology Centre
      • Vadodara, Gujarat, India
        • Desai Urological & Maternity Hospital
    • Gujrat
      • Nadiad, Gujrat, India
        • Muljibhai Patel Urological Hospital
    • Himachal Pradesh
      • Shimla, Himachal Pradesh, India
        • Indira Gandhi Medical College
    • Kerala
      • Kochi, Kerala, India
        • Lourdes Hospital
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452014
        • Choithram Hospital and Research Centre
    • Madya Pradesh
      • Gwalior, Madya Pradesh, India
        • Cancer Hospital and Research Institute
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College
    • Rajasthan
      • Bikaner, Rajasthan, India
        • S.P. Medical College & A. G. of Hospitals
    • West Bengal
      • Kolkata, West Bengal, India
        • 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:

  1. Informed Consent obtained & signed:

    Ability to understand and the willingness to sign a written informed consent document.

  2. Disease characteristics:

    Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ, multiple unresected T1 and Ta high grade.

    BCG-refractory STCC is defined as when there is failure to achieve disease-free state at six months after initiation of BCG therapy either as primary or repeat therapy or recurrence of tumor within three months of completion of adequate induction or maintenance therapy or adequate retreatment. .

  3. Patient Characteristics:

Age: 18 completed years and above Performance status: ECOG 0-2 Life expectancy: At least 24 weeks Hematopoietic:Hemoglobin ≥ 9.0 g/dL

Co-morbidity

  • 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.

Note: The effects of Investigational product on the developing human fetus 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.
  • Intractable urinary tract infection.
  • 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 arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mw
All enrolled patients to receive Mycobacterium w
Immunomodulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: 15 Months
15 Months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Mahesh Desai, MD, Muljibhai Patel Urological Hospital
  • Principal Investigator: Amillal Bhat, MD, S P Medical College & AG of Hospital
  • Principal Investigator: Sushil Bhatia, MD, Choithram Hospital and Research Centre
  • Principal Investigator: Kim Mammen, MD, Christian Medical College, Vellore, India
  • Principal Investigator: Ketan Rajyaguru, MD, Siddhi Vinayak Hospital
  • Principal Investigator: Gaurang Gandhi, MD, Gandhi Urocare
  • Principal Investigator: Kapil Thakkar, MD, Excel Hospital
  • Principal Investigator: B. R. Shrivastav, MD, Cancer Hospital & Research Institute
  • Principal Investigator: Anup Kundu, MD, IPGMER, S.S.K.M. Hospital
  • Principal Investigator: Jitendra Amlani, MD, Urocare Hospital
  • Principal Investigator: Rasesh Desai, MD, Desai Urological and Maternity Hospital
  • Principal Investigator: N. K. Mohanty, MD, V. M. Medical College and Safdarjang hospital
  • Principal Investigator: Shrawan K. Singh, MD, Post Graduate Institute of Medical Education and Research
  • Principal Investigator: Ketan Shukla, MD, Aarogyam Speciality Hospital
  • Principal Investigator: Krishna Moorhty, MD, Lourdes Hospital
  • Principal Investigator: Rajeev Sood, MD, Dr. Ram Manohar Lohia Hospital and PGIMER
  • Principal Investigator: Purshottam K. Puri, MD, Indira Gandhi Medical College, Shimla

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

October 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

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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