A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1

Date Added
November 23rd, 2021
PRO Number
Pro00116487
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Cancer, Drug Studies
Summary

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in the study as long as they are not experiencing bad side effects, comply with the study requirements and or not withdrawn by themselves or the study doctor.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
HCC-CTO@musc.edu

EF-32 (TRIDENT): A Pivotal Randomized, Open-Label Study of Optune® (TTFIELDS, 200KHZ) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Date Added
February 9th, 2021
PRO Number
Pro00106190
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Cancer/Brain, Glioblastoma, Men's Health, Women's Health
Summary

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.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Phase II Study of Metronomic and Targeted Anti-Angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma

Date Added
September 1st, 2020
PRO Number
Pro00091939
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Central Nervous System, Children's Health, Drug Studies, Pediatrics, Spinal Cord
Summary

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.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trails@musc.edu

A Phase 3, Multicenter, Randomized, Double-blind Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Date Added
January 28th, 2020
PRO Number
Pro00094747
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Cancer
Summary

This study evaluates the safety and usefulness of a new investigational drug called AG-881-C-004 in participants with residual or recurrent Grade 2 glioma (a type of brain cancer) that have a IDH1 or IDH2 mutation. Participants will be randomly assigned to take either the study drug or a placebo (a medically inactive substance). If your disease progresses and you were receiving the placebo, you will be given the opportunity to start taking the study drug.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
Kellej@musc.edu

GBM AGILE Trial

Date Added
January 21st, 2020
PRO Number
Pro00089802
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Glioblastoma
Summary

Glioblastoma adaptive, global, innovative learning environment or GBM AGILE trial is to identify effective therapies and improve survival for a type of brian cancer called glioblastoma (GBM) and to match effective therapies with adult patients with newly diagnosed or recurring glioblastoma. Eligible participants will have a 50/50 chance of taking either standard therapy medications or a medication not yet approved by the FDA called regorafenib during their standard of care treatment for GBM.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
Kellej@musc.edu

A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study

Date Added
July 12th, 2016
PRO Number
Pro00056376
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Cancer/Brain, Drug Studies
Summary

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.

Institution
MUSC
Recruitment Contact
Michele DeCandio
843-792-9016
decandio@musc.edu



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