Protocol
11-163
Full Title
A Randomized, Phase 2, Open-Label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma
Purpose
The purpose of this study is to see if giving an investigational drug called DN24-02 after surgery for urothelial cancers (those of the bladder, renal pelvis, ureter, or urethra) helps patients live longer. DN24-02 works by boosting the power of the immune system against the cancer by recognizing a protein on some tumor cells called HER2/neu.
Patients will be randomly assigned to receive DN24-02 or not. Those who do not receive the study drug will undergo periodic assessment with their doctors.
Patients who receive DN24-02 will have some of their white blood cells removed through a process called leukapheresis. The white blood cells are mixed in the laboratory with DN24-02 and then returned to the patient. The modified white blood cells recognize HER2/neu and prompt the immune system to identify and kill cancer cells.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have HER2-positive urothelial cancer that has been completely surgically removed (no partial cystectomy or nephrectomy) and is determined to have a high risk of recurrence.
- For patients who had therapy before surgery, at least 60 days must have passed since completion of treatment and entry into the study.
- Patients may not have had chemotherapy or radiation therapy for their cancer after surgery.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-422-4333.
Disease(s)
Bladder Cancer
Locations
Related Diseases
