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  • A Phase 1 And Randomized Phase 2 Trial Of Selinexor And Temozolomide In Recurrent Glioblastoma Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of phase 1 of this trial is to determine the maximum tolerated dose of temozolomide followed by selinexor in recurrent glioblastoma patients as determined by dose-limiting toxicities [DLTs] and the total toxicity profile.

    The purpose of phase 2 of this trial is to evaluate the effectiveness of sequentially administering temozolomide and selinexor in recurrent glioblastoma as determined by progression-free survival [PFS].
  • A Phase 1 Dose Escalation And Randomized Expansion Study Of The Safety, Tolerability, And Pharmacokinetics Of MT-125 Monotherapy With Radiation In Patients With Newly Diagnosed Glioblastoma Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.

    Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.

    Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to destroy them. It will be administered on the same day as your standard of care radiotherapy because it is also designed to help radiotherapy work better. However, this is the first time MT-125 will be studied in humans. Therefore, the use is considered investigational. If you would like more details about MT-125 in glioblastoma participants, please ask the Study Doctor.

    You will be among the first participants with glioblastoma to receive this study treatment. Its safety and effectiveness have not yet been established in humans. Thus, we do not know whether it will work for you. Your condition may improve, may get worse, or there may be no change.

    The selected participant population-individuals newly diagnosed with histologically and/or molecularly confirmed IDH wild-type, MGMT-unmethylated glioblastoma-represents those least likely to experience safety concerns or adverse events related to the study treatment, and most likely to derive therapeutic benefit.

    There are certain tests/questions you must complete to find out if you meet the requirements to be in the study. If you do not meet these requirements, you cannot take part in the study. If this happens, you can talk to your Study Doctor about other options.
  • A Phase 3, Multicenter, Clinical Study To Evaluate The Efficacy And Safety Of Safusidenib Erbumine In Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.

    The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.

    The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.
  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of Optune® (TTFields, 200 KHz) Concomitant With Maintenance Temozolomide And Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide And Placebo For The Treatment Of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58). Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
  • A Phase II Open Label, Randomized Study Testing The Efficacy Of Retifanlimab In Combination With Bevacizumab And Hypofractionated Radiotherapy In Patients With Recurrent GBM Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz. This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.
  • MC240703: Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol Rochester, Minn., Jacksonville, Fla.

    This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while addressing a great health disparity in patients with glioma.
  • Pilot Feasibility Study Of Tumor Treating Fields In Treatment Of Leptomeningeal Metastases Involving The Spine Jacksonville, Fla. This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.

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