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

NCT ID: NCT00694798

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mw

All enrolled patients to receive Mycobacterium w

Group Type: EXPERIMENTAL

Mycobacterium w

Intervention Type: BIOLOGICAL

Immunomodulator

Interventions

Mycobacterium w

Immunomodulator

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cadila Pharnmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahesh Desai, MD

Role: PRINCIPAL_INVESTIGATOR

Muljibhai Patel Urological Hospital

Amillal Bhat, MD

Role: PRINCIPAL_INVESTIGATOR

S P Medical College & AG of Hospital

Sushil Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

Choithram Hospital and Research Centre

Kim Mammen, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Ketan Rajyaguru, MD

Role: PRINCIPAL_INVESTIGATOR

Siddhi Vinayak Hospital

Gaurang Gandhi, MD

Role: PRINCIPAL_INVESTIGATOR

Gandhi Urocare

Kapil Thakkar, MD

Role: PRINCIPAL_INVESTIGATOR

Excel Hospital

B. R. Shrivastav, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital & Research Institute

Anup Kundu, MD

Role: PRINCIPAL_INVESTIGATOR

IPGMER, S.S.K.M. Hospital

Jitendra Amlani, MD

Role: PRINCIPAL_INVESTIGATOR

Urocare Hospital

Rasesh Desai, MD

Role: PRINCIPAL_INVESTIGATOR

Desai Urological and Maternity Hospital

N. K. Mohanty, MD

Role: PRINCIPAL_INVESTIGATOR

V. M. Medical College and Safdarjang hospital

Shrawan K. Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Ketan Shukla, MD

Role: PRINCIPAL_INVESTIGATOR

Aarogyam Speciality Hospital

Krishna Moorhty, MD

Role: PRINCIPAL_INVESTIGATOR

Lourdes hospital

Rajeev Sood, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Ram Manohar Lohia Hospital and PGIMER

Purshottam K. Puri, MD

Role: PRINCIPAL_INVESTIGATOR

Indira Gandhi Medical College, Shimla

Locations

Aarogyam Speciality Hospital

Ahmedabad, Gujarat, India

Gandhi Urocare

Ahmedabad, Gujarat, India

Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre

Ahmedabad, Gujarat, India

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, India

Urocare Hospital

Rajkot, Gujarat, India

Excel Hospital, Advanced Laproscopy and Urology Centre

Surat, Gujarat, India

Desai Urological & Maternity Hospital

Vadodara, Gujarat, India

Indira Gandhi Medical College

Shimla, Himachal Pradesh, India

Lourdes Hospital

Kochi, Kerala, India

Choithram Hospital and Research Centre

Indore, Madhya Pradesh, India

Cancer Hospital and Research Institute

Gwalior, Madya Pradesh, India

Christian Medical College

Ludhiana, Punjab, India

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

Bikaner, Rajasthan, India

IPGMER, S.S.K.M. Hospital

Kolkata, West Bengal, India

Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Dr. Ram Manohar Lohia Hospital & PGIMER

New Delhi, , India

V. M. Medical College & Safdarjang Hospital

New Delhi, , India

Countries

India

Other Identifiers

CR-80/8230

Identifier Type: -

Identifier Source: org_study_id