The purpose of conducting this observational research study is to gain a better understanding of the impact of GBM on patients and their caregivers at specific time points during treatment. In addition, this study will also examine the approaches currently employed to treat GBM at cancer centers, and how those approaches vary across the course of the disease. As a caregiver of a patient with GBM, participation in this study will provide insights into caregiver quality of life and burden, and how it is affected by GBM.
This study is for patients 22 and older with a glioblastoma (a type of brain tumor) that has grown back (recurred) or not gotten better after being treated with bevacizumab. The purpose of this study is to test any good and bad effects of adding bevacizumab to a type of therapy for brain tumors called Optune. Optune is a portable device that produces electrical signals, called Tumor Treating Fields ("TTFields"). Optune is a portable device worn on the patients head that send wave-like electric signals directly to their tumor. The device will be worn continuously throughout the day for at least 18 hours a day with breaks allowed for personal needs.
The main purpose of this study is to research the investigational drug (not yet approved by the Food and Drug Administration), ABT414. Human studies have shown ABT-414 can shrink EGFR (epidermal growth factor receptor)-amplified glioblastomas (GBM's) in some people whose tumors were growing despite earlier RT (radiation) and chemotherapy treatment. This investigational drug will be given at the same with radiation therapy and the FDA approved chemotherapy drug, temozolomide.
If the subject meets the study requirements and agrees to volunteer, they will be on the study for approximately 2 years, and will be asked to go to study visits every 2 weeks.
Approximately 720 subjects will be asked to take part, 8 of them will be at MUSC.
The purpose of this study is to determine if the investigational products, Toca 511 and Toca FC, as a combination treatment is effective (works) and safe, compared to a selected number of approved treatments for brain tumors, called a control treatment. Toca 511 is a live virus that has been built to carry a gene into cancer cells. This gene carries instructions that cause the cancer cells to turn Toca FC into a drug that may kill the cancer cells. Toca FC is an investigational extended-release form of flucytosine (5-FC). Flucytosine is a drug approved to treat fungal infections; however, it is not approved for the treatment of brain tumors. This study will examine whether your tumor grows back after surgery and treatment with either Toca 511 and Toca FC combination treatment or the control treatment, and whether you will live longer.