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

Cadila Pharnmaceuticals17 sites in 1 country22 target enrollmentOctober 2008

ConditionsBladder Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Cadila Pharnmaceuticals
Enrollment: 22
Locations: 17
Primary Endpoint: Response Rate
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cadila Pharnmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

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