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Bladder Cancer - Phase IIb Clinical Trial of BC-819

 

For information on this trial in Hebrew, click here for the Israel Cancer Association (external link)

Purpose

This study is designed to assess the efficacy and safety of 20 mg dose of BC-819 with PEI, given as six intravesical instillations into the bladder of patients with intermediate risk superficial bladder cancer, who have failed prior intravesical therapies (BCG or chemotherapy).
The primary efficacy objective is a determination regardingthe ablative effect of BC-819 on a marker tumor, and the prevention of new tumors after the induction course of 6 weekly intravesical administrations of BC-819.

Secondary objectives include determining the long-term continued absence rates of bladder cancer, and time to tumor recurrence in those patients who had a complete response after the induction course.

Inclusion/Exclusion Criteria

To be eligible to participate in this study, patients must meet a number of inclusion/exclusion criteria.

Treatment:

The study is a non-randomized, open label, single group assignment, safety/efficacy study.
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 BC-819, complexed with PEI, into the urinary bladder. Intravesical therapy will be delivered through a catheter.

Patients with complete response will be eligible to receive three additional courses of 3 weekly intravesical administrations of BC-819, complexed with PEI, every 12 weeks (complete tumor response defined as complete ablation of the marker tumor and no evidence of other new or recurrent tumors).

Enrollment information

Current trial locations are:

# Medical Center Location Principal Researcher
1 BCG Oncology Phoenix, AZ, USA Donald Lamm, MD
2 Assaf Harofe Tsrifin, Israel Arie Lindner, MD
3 Bnei Tzion Haifa, Israel Sarel Halachmi, MD
4 Hadassah Jerusalem, Israel Vladimir Yutkin, MD
5 Hillel Yafe Hadera, Israel Nachum Ehrlich, MD
6 Meir Kfar Saba, Israel Ilan Lebovitch, MD
7 Sheba Ramat Gan, Israel Zohar Dotan, MD
8 Wolfson Holon, Israel Ami Sidi, MD

For more information fill the information request form. Continue to check this website as trial information and locations are being updated periodically.