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
1. Informed Consent obtained & signed:
Ability to understand and the willingness to sign a written informed consent
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
- 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
- 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.
- Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the
- 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
- 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.