Kurt A. Jaeckle, M.D.

The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.

The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction stereotactic radiosurgery with or without ipilimumab may work better in treating participants with grade II-III meningioma.

This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

The purpose of this study is to evaluate the effectiveness of ONC201 administered following radiotherapy in participants with H3 K27M-mutant diffuse glioma.

The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I),  and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).

The purpose of this study is to evaluate the safety and feasibility of the spinal array in treatment of patients with leptomeningeal metastases within the spine

The median survival of patients with LM with treatment is generally less than 5 months. There are four FDA-approved drugs for intra-CSF use in LM, but all have shown limited activity with no clear increase in survival outcome with treatment. Intra-CSF treatment is also invasive, involving either surgical placement of an intraventricular reservoir, or treatment (intrathecal) via repetitive lumbar punctures, and there is risk of adverse events including vomiting, headache, arachnoiditis and leukoencephalopathy with treatment. Systemic chemotherapy, targeted agents and immunotherapy have largely been ineffective in treatment of LM, in part due to limited CNS/CSF penetration. New effective treatments are needed.

TTF represents a new modality that is well tolerated with minimal adverse events. TTF has not produced significant additive toxicity when combined with systemic treatments. In addition, no invasive procedures are required, and treatment has been administered for long term without apparent cumulative toxicities.  TTF is currently approved for treatment of glioblastoma and mesothelioma. TTF is currently under study for treatment of CNS parenchymal metastases, lung and pancreatic cancer. There is potential application for symptomatic treatment of LM and intradural, extradural and vertebral metastases. Given the lack of effective therapies for LM, TTF is a promising alternative modality that should be explored. In addition, the lack of overlapping toxicities would potentially allow the use of TTFields in conjunction with other ongoing treatments for the leptomeningeal or systemic cancer. For these reasons, we are proposing an exploratory, phase I feasibility study of TTFields in treatment of the spinal component of leptomeningeal metastases, If feasible, consideration will be given to expansion to a Phase 1/2 study in a selected cohort of patient with LM.  

The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I),  and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).

The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.

The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction stereotactic radiosurgery with or without ipilimumab may work better in treating participants with grade II-III meningioma.

The purpose of this study is to evaluate the side effects and best dose of  CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with radiation therapy and temozolomide may work better in treating participants with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.

The purpose of this study is to evaluate the safety and tolerability of marizomib in combination with Temozolomide-based radiochemotherapy versus standard Temozolomide-based radiochemotherapy alone in newly diagnosed glioblastoma patients. 

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

The purpose of this study is to compare the effectiveness of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization.

The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.

The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.

The primary goal of this project is to collect human nervous system tissue, blood-derived, and cerebrospinal fluid specimens for storage.

The purpose of this project is to provide expanded access to ONC201 for patients with previously-treated H3 K27M-mutant and/or midline high grade gliomas who cannot access ONC201 through clinical trials.