Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma...
Vestibular SchwannomaMeningioma2 moreThis will be a multi-center, proof of concept phase 0 study to assess the suppression of p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing tumor resection. AR-42 is a small molecule which crosses the blood brain barrier (BBB) in rodents, but the investigators are not certain yet if it will penetrate human VS. Meningiomas are outside the BBB, but seem to be unusually resistant to all current medical treatments. The primary endpoint of the bioactivity of suppression of p-AKT by AR-42 was selected as drug activity seems more informative than bioavailability. Our preclinical data and others have shown dose dependent suppression of p-AKT by AR-42 in both VS and meningiomas.
Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed,...
Brain and Central Nervous System TumorsRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not yet known whether radiation therapy or radiosurgery is more effective than observation alone in treating benign meningioma. PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see how well they work compared to observation alone in treating patients with newly diagnosed, benign meningioma that has been partially removed by surgery.
Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory...
Childhood Choroid Plexus TumorChildhood Ependymoblastoma17 moreThis phase I trial studies the side effects and best dose of palbociclib isethionate in treating younger patients with central nervous system tumors that have grown, come back, or not responded to treatment. Palbociclib isethionate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent...
MeningiomaMeningioma1 moreMeningioma is the most common central nervous system (CNS) tumor and accounts for approximately 30% of all CNS tumors. For meningioma recurring after surgery and radiation therapy, there is no effective medical therapy. Repeat surgery or radiation therapy may be possible, but they are temporizing measures with limited durable relief. PD-L1 expression in meningioma is increased for recurrent tumors or prior radiation therapy, and a recent case study reported significant reduction of an intracranial meningioma after 6 months of PD-L1 blockade. Radiation has been shown to augment immune response when combined with PD-L1 blockade. Proton radiation therapy has higher relative biological effectiveness (RBE) and may further amplify the above immunological signals. Combination of proton radiation therapy administered concurrently with PD-L1 inhibitor may maximize immune response for recurrent meningioma. However, confirmation of the increased immunogenicity or increased tumor infiltrating lymphocytes using the combination of radiation therapy and PD-L1 blockade have not been confirmed in patients. The proposed study will be a single institution, single-arm, open-label, phase Ib study to combine neoadjuvant avelumab (a PD-L1 inhibitor) with hypofractionated proton therapy of 20 CGE (cobalt gray equivalent) over 5 fractions followed by planned surgery for recurrent radiation-refractory meningioma. This study is designed to provide proof of concept to demonstrate on-target effect of the combination to increase immunogenicity by directly examining the resected tumor for immune response and to evaluate preliminary clinical efficacy
S9624 Ifosfamide in Treating Patients With Meningeal Tumors
ChondrosarcomaAdult Fibrosarcoma4 moreRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ifosfamide in treating patients with meningeal tumors that have recurred or that cannot be removed surgically.
Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive...
Intracranial MeningiomaIn this multicenter, Phase II trial, the investigators plan to evaluate the activity of the combination of bevacizumab and everolimus in patients with recurrent, progressive meningioma following maximal treatment with surgical resection and local radiation therapy. Although these patients are relatively rare, there is currently no established standard of treatment for a disease that causes a great deal of morbidity, and that is eventually fatal.
Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors
Recurrent GliomaHigh-grade Meningioma1 moreThis is an open label phase I clinical trial with two arms, representing single and fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for 2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no intra-patient dose escalation. Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of 1st fraction of radiation. Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or tomotherapy technology.
Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
MeningiomaThis is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior
S9005 Mifepristone in Meningioma
MeningiomaTo compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma.
Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas
Recurrent MeningiomasResistant MeningiomasTo determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.