Conditions: Superficial Bladder Cancer
Keywords: BCG Refractory or Relapsed Superficial Bladder Cancer rAd-IFN Syn3 Intravesical transitional cell carcinoma of the bladder superficial non-muscle invasive tumor Interferon alpha2b INSTILADRIN
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief 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.

Detailed description:
Criteria for Evaluation:

Efficacy: A Response is defined as no evidence of recurrence of a high grade tumor by cystoscopy, cytology or if clinically indicated, biopsy.

Safety: The safety and tolerability of INSTILADRIN will be evaluated based on adverse event reports, vital signs, ECGs, clinical laboratory values and results of physical examination.

Arms:
arm 1: Subjects will be randomly assigned to one of two INSTILADRIN arms. arm 2: Subjects will be randomly assigned to one of two INSTILADRIN arms.

Interventions: intervention 1: INSTILADRIN
Intervention descriptions: intervention 1: The INSTILADRIN components will be mixed with a diluent. The total dose will be given as a single, one-hour intravesical administration which may, depending on clinical response, be repeated every 3 months up to a maximum of 4 instillations.

Protocol document: