A Phase II, Randomized, Open Label, Parallel Arm Study to Evaluate the Safety and Efficacy of rAd-IFN/Syn3 Following Intravesical Administration in Subjects with High Grade, BCG Refractory Relapsed Non-Muscle Invasive Bladder Cancer (NMIBC)
This Phase ii study is designed to evaluate the efficacy and safety of rad-iFn/Syn3 in subjects with high grade nMiBC that is refractory or resistant to, or who have relapsed following, BCG treatment.
1. Aged 18 years or older at the time of consent
2. Able to give informed consent
3. Subjects with high grade BCG-refractory or relapsed NMIBC defined as:
* High grade non-invasive papillary carcinomas (Ta) and subjects with high grade
tumors that invade sub-epithelial connective tissue (T1) or
* Carcinoma in situ (CIS) only or
* CIS and Ta or T1 tumors
Refractory is defined as failure to achieve a disease-free state at six months after
adequate induction of BCG therapy with either maintenance or re-induction at
3 months. Adequate induction is defined as a minimum of 5 out of 6 induction doses
and adequate maintenance is defined as a minimum of 2 out of 3 doses of treatment.
Relapse is defined as recurrence within year 1 after a complete response to BCG treatment.
4. Complete resection of visible papillary lesions or CIS by TURBT or endoscopic
resection between 14 and 60 days prior to beginning study treatment
5. Available for the whole duration of the study
6. Life expectancy >2 years, in the opinion of the investigator
7. ECOG status 2 or less
8. Absence of upper tract urothelial carcinoma
9. Female subjects of childbearing potential must use maximally effective birth control
during the period of therapy, must be willing to use contraception for 1 month
following the last study drug infusion and must have a negative urine or serum
pregnancy test upon entry into this study. Otherwise, female subjects must be
postmenopausal (no menstrual period for a minimum of 12 months) or surgically
10. Male subjects must be surgically sterile or willing to use a double barrier contraception
method upon enrolment, during the course of the study, and for 1 month following the
last study drug infusion.
11. Adequate laboratory values.
* Hemoglobin >=10 g/dL.
* WBC >=4000/[MICRO-SYMBOL]L.
* ANC >=2000/[MICRO-SYMBOL]L.
* Platelet count >=100,000/[MICRO-SYMBOL]L.
* INR within institutional normal limits.
* aPTT within institutional normal limits.
* AST <=1.5 x ULN.
* ALT <=1.5 x ULN.
* Total bilirubin within institutional normal limits.
* Creatinine <=1.5 x ULN.
"It is accepted that patients receiving anticoagulation therapy would not have INR and aPTT results that fall within 'normal limits'. It is not intended to exclude these patients and therefore medical discretion is permitted for patients who have clinically acceptable results in regards to their current concomitant anticoagulant therapy."