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

Bladder Cancer Clinical Trial

— STCC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694798
• Other study ID #: CR-80/8230
• Status: Completed
• Phase: Phase 1
• First received: June 3, 2008
• Last updated: May 2, 2012
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: May 2012
• Source: Cadila Pharnmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell

Intervention

Biological:
• Mycobacterium w
Immunomodulator

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Pharnmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		15 Months	No