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

NCT00694798 | Completed Phase 1 DMC

• 1 other identifier: CR-80/8230
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 17

Brief 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

Bladder Cancer

Keywords

STCC; Superficial Transitional Cell Carcinoma- BCG refractor

Outcome Measures

Primary Outcomes (1)

• Response Rate

  15 Months

Study Arms (1)

Mw

EXPERIMENTAL

All enrolled patients to receive Mycobacterium w

Biological: Mycobacterium w

Interventions

Mycobacterium w BIOLOGICAL

Immunomodulator

Mw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent obtained \& signed:
• Ability to understand and the willingness to sign a written informed consent document.
• 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. .
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead

Study Sites (17)

Aarogyam Speciality Hospital

Ahmedabad, Gujarat, India

Location

Gandhi Urocare

Ahmedabad, Gujarat, India

Location

Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre

Ahmedabad, Gujarat, India

Location

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, India

Location

Urocare Hospital

Rajkot, Gujarat, India

Location

Excel Hospital, Advanced Laproscopy and Urology Centre

Surat, Gujarat, India

Location

Desai Urological & Maternity Hospital

Vadodara, Gujarat, India

Location

Indira Gandhi Medical College

Shimla, Himachal Pradesh, India

Location

Lourdes Hospital

Kochi, Kerala, India

Location

Choithram Hospital and Research Centre

Indore, Madhya Pradesh, 452014, India

Location

Cancer Hospital and Research Institute

Gwalior, Madya Pradesh, India

Location

Christian Medical College

Ludhiana, Punjab, 141008, India

Location

S.P. Medical College & A. G. of Hospitals

Bikaner, Rajasthan, India

Location

IPGMER, S.S.K.M. Hospital

Kolkata, West Bengal, India

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Location

Dr. Ram Manohar Lohia Hospital & PGIMER

New Delhi, India

Location

V. M. Medical College & Safdarjang Hospital

New Delhi, India

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Mycobacterium w vaccine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• 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, Chandigarh

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 11, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

IN (17)