ALTOR: A Comparison of Two Treatments for Non-Invasive Bladder Cancer

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Age:
18 and older
Gender:
Any
Healthy Volunteers:
No
Keywords:
Non-Muscle Invasive Bladder Cancer, Bladder Cancer, BCG, ALT-803, Altor, Bacillus Calmette-Guerin, cancer, cytokine, IL-15, bladder
Type:
Drug
Target:
10 Participants
Description
Non-invasive bladder cancer occurs in the cells that line the inside of the bladder. This type of cancer can be treated with intravesical therapy. Intravesical therapy is when a doctor uses a catheter to put treatment straight into the bladder.

One type of intravesical treatment for bladder cancer is Bacillus Calmette-Guerin (BCG). BCG is an immunotherapy, which means it causes the body’s immune system to fight the cancer cells. BCG is derived from the germ that causes tuberculosis but it does not cause serious disease in humans.

Similar to BCG, ALT-803 is also an intravesical immunotherapy (experimental). ALT-803 is a small protein that signals specific cells in the immune system to attack cancer tumor cells.

The purpose of this study is to compare the combination of BCG and ALT-803 to BCG alone. This comparison is being done to test if the combination treatment would be better.
This study requires
Your participation in the Study will include up to six (6) weekly doses of BCG plus ALT-803 or BCG alone.
After the treatment is placed within your bladder, you will be asked to stay in the treatment center for up to four hours, so that we can carefully monitor your body’s functions and closely watch for potential side effects of the Study drug on your body.

Other standard medical and urology related examinations will be performed throughout the study. Follow up visits will also be required.

A more detailed schedule of events can be found below in the informed consent form.
Who can participate?
Women and men 18 years and older with non-muscle invasive bladder cancer of the transitional cell carcinoma high-risk subtype.

A more detailed inclusion exclusion criteria can be found below in the informed consent form.
Benefits and risks of participating
Risks and possible benefits may be found in the informed consent document attached below
Compensation
No compensation is provided for participation in this study
Resources
PDF Docs
Informed Consent Form
Schedule
Study duration and period
We expect that you will be in this research study for up to two (2) years.
Recruitment period
From April 1, 2017
Location
UC Davis Urology Clinic
4680 Y Street
suite 2200
Sacramento, CA 95817
Contact
Mark W Alger