A Randomized, Phase 2, Open Label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma
ID Number 12-0709Principal Investigator(s)
Simon J. Hall
Department(s) or Division(s)
The purpose of this study is to study an immune system treatment for urothelial (bladder, renal pelvis, urethra or ureter) cancers called DN24 02. DN24-02 uses cells, called antigen presenting cells, which are prepared from your own blood. An antigen is a substance, in this case a protein, which may cause the body to make a specific immune response. Antigen presenting cells are a type of white blood cell (cells that fight cancer and infections), and they are important to the immune system because they teach other white blood cells to recognize specific substances on other cells in your body. These blood cells are removed from your body, cultured with an antigen in the laboratory, and then put back into your body. Training your white blood cells to recognize markers may help your immune system find and attack cancer cells.
If you enter this study, a computer will determine by chance (like pulling names out of a hat) whether you receive DN24 02 or do not receive DN24 02. There is a 1 in 2 chance that you will receive DN24 02. Neither you nor your study doctor will know whether you will receive DN24-02 until you enter the study.
The study compares patients who receive DN24 02 to patients who do not receive DN24 02. The main purpose of the study is to learn if DN24 02 helps patients to live longer. Other purposes of the study are to learn about the safety of DN24 02, to learn if it delays the time until urothelial (bladder, renal pelvis, urethra or ureter) cancer returns, and to learn if the immune system responds to treatment with DN24 02.
DN24-02 is an investigational treatment, which means that it has not been approved for commercial use by the United States Food and Drug Administration (FDA).
You may qualify to take part in this research study because you have urothelial cancer, have had surgery to remove the cancer, and you have a high risk of the cancer returning.
Recruiting Patients: Yes