The purpose of this study is to learn more about safety and effects (good or bad) of FCN-159 as a potential new treatment option for people with neurofibromatosis type (NF1). NF1 is a genetic disorder caused by the mutation of a gene that is responsible for producing a protein called neurofibromin, which is needed for the function of many cells. FCN-159 is not approved by the Food and Drug Administration (FDA) or any other health authority. This is a Phase I study, which means that this experimental drug is either being studied for the first time in humans or has been tested a limited number of times in humans. There is also a Phase II portion to this study where the study team hopes to learn more about safety and effects (good or bad) of FCN-159 as a potential new treatment option for people with NF1. Depending on when a participant enrolls in this study, he/she will receive higher doses of FCN-159 until the safest and best tolerated dose is reached. FCN-159 is a tablet that participants will take by mouth in a fasting state (no food or drink 1 hour before and 2 hours after each dose) once daily for 28 days. The experimental drug, FCN-159, may or may not be helpful in the treatment of NF1 condition. There are risks to this study drug. Participants on the study may remain on the study as long as they do not experience bad reactions, experience disease progression, or decide not to participate. Participants may remain in the study as long as they are not experiencing bad side effects, comply with the study requirements and or not withdrawn by themselves or the study doctor.
This trial is for newly diagnosed glioblastoma (GBM) patients who, after surgery or biopsy, are good candidates for radiation therapy (RT) and temozolomide (TMZ) treatments. The purpose of this study is to see how safe and how well a medical device called Optune works together with the other standard of care treatments for GBM (RT and TMZ). Optune is a device that uses Tumor Treating Fields (TTFields) which are low intensity electric fields that interfere with the division process of cancer cells. Optune has been approved for the treatment of recurrent and newly diagnosed GBM by the Food and Drug Administration (FDA) in the United States. Participants in this study will be randomly assigned to one of two groups:
-The Experimental Group: TTFields using the Optune system upfront with RT and TMZ followed by the use of Optune and TMZ
-The Control Group: Beginning treatment of RT and TMZ, followed by the use of Optune and TMZ
Patients will have clinic visits every 4 weeks and continue on TTFields for 24 months until their disease gets worse or they or their doctor decided to stop treatment.
This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.
Subjects are being asked to volunteer for a research study because they have their first anaplastic astrocytoma (AA) tumor progression (worsening) or recurrence.
The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Eflornithine is an experimental drug that the United States Food and Drug Administration (FDA) has not approved it for use by the general public. Lomustine has been approved by the FDA in the United States for this patient population.