A Phase II, Randomized, Open Label, Parallel Arm Study to Evaluate the Safetyand Efficacy of rAd-IFN/Syn3 Following Intravesical Administration in Subjects with High Grade, BCG Refractory or Relapsed Non-Muscle Invasive Bladder Cancer (NMIBC)
This research is being done to evaluate the effectiveness and safety of the investigational agent Instiladrinï¿½ (rAd-IFN) given up to four times into the bladder in people with bladder cancer, who have failed or progressed after other treatment including BCG therapy for bladder cancer. Instiladrin has previously been tested when given as a one-time dose into the bladder in 24 subjects with bladder cancer. Instiladrinï¿½ (rAd-IFN) uses a virus to help express the drug interferon into the cells lining the bladder. Utilizing the virus allows interferon to stay in the bladder for a longer period of time. The longer exposure and repeated administration of rAd-IFN in the bladder may allow it to be more effective against bladder cancer.
18 or older; high-grade BCG-refractory; or relapsed non-muscle invasive bladder cancer.
Randomized, open label, parallel arm, Phase II study of rAd-IFN/Syn3 administered intravesically in subjects with high grade BCG refractory or relapsed NMIBC. Study will enroll 2 treatment groups of 20 subjects each. Subjects in the rAd-IFN/Syn3 treatment groups will be randomized to receive a 75 mL intravesical administration of rAd-IFN/Syn3 at a treatment dose of either 1 x 1011 vp/ml or 3 x 1011 vp/ml on Day 1 of the study. Subjects may be re-treated with the same dose at the Month 4, 7 and 10 time points. The decision to repeat treatment will be determined by the clinical response observed. Subjects can receive up to four intravesical administrations of rAd-IFN/Syn3 over the 12 month in-life phase of the study.At 3,6 and 9 months post start of treatment, all subjects will be evaluated for recurrence of high grade disease. Cystoscopy, cytology, and,biopsies will be performed to obtain accurate staging. If no evidence of recurrence is detected, a further dose of rAd-IFN/Syn3 will be administered as maintenance therapy. Subjects who have recurrence of high grade disease will be withdrawn from treatment but followed for survival and time to cystectomy. Following withdrawal all subjects will undergo a safety assessment a minimum of30 days after the last treatment. At 12 months, a final efficacy evaluation will be performed. This will include cystoscopy cytology, and biopsies.
12/11/2013 04:02 AM