Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder C… (NCT01687244) | Clinical Trial Compass
CompletedPhase 2
Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer
40 participantsStarted 2012-09
Plain-language summary
This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with Syn3) when given intravesically to patients with high grade non-muscle invasive bladder cancer who are refractory to or have relapsed from BCG therapy. The pharmacodynamics of INSTILADRIN will also be studied by measuring the interferon (IFNα2b) levels excreted in the urine. rAd-IFN is a non-replicating recombinant adenovirus type 5 (Ad5)-vector encoding the interferon alpha-2b (IFNα2b) gene. Syn 3 is clinical surfactant excipient which enhances the ability of the adenoviral vector to transfect cells in the bladder wall.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18 years or older at the time of consent
✓. Able to give informed consent
✓. Subjects with high grade BCG-refractory or relapsed NMIBC including
✓. Complete resection of visible papillary lesions or CIS by TURBT or endoscopic resection between 14 and 60 days prior to beginning study treatment
✓. Available for the whole duration of the study
✓. Life expectancy \>2 years, in the opinion of the investigator
✓. ECOG status 2 or less
✓. Absence of upper tract urothelial carcinoma
Exclusion criteria
✕. Current or previous evidence of muscle invasive or metastatic disease
✕. Current systemic therapy for bladder cancer
✕. Current or prior pelvic external beam radiotherapy
✕. Prior treatment with adenovirus-based drugs
✕. Suspected hypersensitivity to interferon alpha
✕. Existing urinary tract infection or bacterial cystitis
What they're measuring
1
Incidence of High Grade-Recurrence Free Survival at 360 Days