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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer	Biological: Mycobacterium w	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	22 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	October 2008
Actual Primary Completion Date :	July 2011
Actual Study Completion Date :	July 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Mw; All enrolled patients to receive Mycobacterium w	Biological: Mycobacterium w; Immunomodulator

Outcome Measures

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Primary Outcome Measures :

1. Response Rate [ Time Frame: 15 Months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

India
Aarogyam Speciality Hospital
Ahmedabad, Gujarat, India
Gandhi Urocare
Ahmedabad, Gujarat, India
Siddhi Vinayak Hospital, Advanced Urology and Orthopedic Centre
Ahmedabad, Gujarat, India
Urocare Hospital
Rajkot, Gujarat, India
Excel Hospital, Advanced Laproscopy and Urology Centre
Surat, Gujarat, India
Desai Urological & Maternity Hospital
Vadodara, Gujarat, India
Muljibhai Patel Urological Hospital
Nadiad, Gujrat, India
Indira Gandhi Medical College
Shimla, Himachal Pradesh, India
Lourdes Hospital
Kochi, Kerala, India
Choithram Hospital and Research Centre
Indore, Madhya Pradesh, India, 452014
Cancer Hospital and Research Institute
Gwalior, Madya Pradesh, India
Christian Medical College
Ludhiana, Punjab, India, 141008
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

Sponsors and Collaborators

Cadila Pharnmaceuticals

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:	NCT00694798 History of Changes
Other Study ID Numbers:	CR-80/8230
First Posted:	June 11, 2008
Last Update Posted:	May 3, 2012
Last Verified:	May 2012

Keywords provided by Cadila Pharnmaceuticals:

STCC; Superficial Transitional Cell Carcinoma- BCG refractor

Additional relevant MeSH terms:

Carcinoma; Urinary Bladder Neoplasms; Mycobacterium Infections; Carcinoma, Transitional Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms	Urogenital Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Urologic Diseases; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections