NCT00595088

Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer

Phase 2b, Multicenter Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Anchiano Therapeutics Israel Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the efficacy and safety of DTA-H19/PEI given as six intravesical instillations of 20 mg of plasmid DNA complexed with PEI into the bladder of patients with intermediate risk superficial bladder cancer \[recurrent stages Ta (low or high grade)and T1, (low grade) transitional cell carcinoma (TCC)\] who have failed prior intravesical therapies including either Bacillus Calmette-Guérin (BCG) or chemotherapy. The primary efficacy objective is to determine the effect of DTA-H19/PEI on the prevention of new tumors after the induction course of 6 weekly intravesical administrations of investigational product assessed 8 to 10 weeks after the start of treatment. Secondary objectives include assessing the ablative effect of DTA-H19/PEI on a marker tumor, safety assessed by the incidence and severity of adverse events, determining the long-term (46 weeks) continued rates of absence of bladder cancer, and time to tumor recurrence in those patients who had a complete response (CR) after the induction course.

Detailed description

DTA-H19, is a doubled stranded DNA plasmid that carries the gene for the diphtheria toxin A (DT-A) chain under the regulation of the H19 promoter sequence. This is a Patient-Oriented, Targeted Therapy as DT-A chain expression is triggered by the presence of H19 transcription factors that are upregulated in tumor cells. The selective initiation of toxin expression results in selective tumor cell destruction via inhibition of protein synthesis in the tumor cell, enabling highly targeted cancer treatment.

Conditions

• Superficial Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BC-819/PEI	Papillary tumors will be resected with the exception of one marker tumor that will remain to examine the effects of the treatment on the remaining tumor. Study treatments will consist of an induction course of six weekly instillations of 20 mg of DTA-H19/PEI into the urinary bladder. Intravesical therapy will be delivered through a Foley catheter. Patients will be instructed to hold the dose in the bladder for two hours after administration. If the patient has a complete response, then she/he will be eligible to receive three additional courses of 3 weekly intravesical administrations of the same dose of investigational product every 12 weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2008-01-16
• Last updated: 2019-04-30
• Results posted: 2013-08-21

Locations

6 sites across 2 countries: United States, Israel