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Meningioma clinical trials

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NCT ID: NCT03604978 Recruiting - Clinical trials for Recurrent Meningioma

Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma

Start date: June 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies 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 patients with grade II-III meningioma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and 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. Giving nivolumab and multi-fraction stereotactic radiosurgery with or without ipilimumab may work better in treating patients with grade II-III meningioma.

NCT ID: NCT03583528 Recruiting - Neuroblastoma Clinical Trials

DOTATOC PET/CT for Imaging NET Patients

Start date: July 11, 2018
Phase:
Study type: Observational

Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs. This study proposes 68Gallium(68Ga)-DOTATOC positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the safety and sensitivity of 68Ga-DOTATOC PET/CT at detecting NETs and other tumors with over-expression of somatostatin receptors.

NCT ID: NCT03567486 Recruiting - Clinical trials for Tuberculum Sellae Meningioma

Predictive Factors of Visual Recovery After Paraoptic Tumors Removal

PRONOPTIC
Start date: December 18, 2017
Phase:
Study type: Observational

Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer thinning on OCT. We propose to perform a single center prospective study in which detailed preoperative ophthalmological and radiological criteria will be collected before surgery. Intraoperative information will be noted as well. All these data will be statistically examined regarding the postoperative visual recovery at 3, 6 and 12 months

NCT ID: NCT03558516 Completed - Meningioma Clinical Trials

Magnesium and Intraoperative Blood Loss in Meningioma Surgery

Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

Meningioma is the most common central nervous system tumor and craniotomy with tumor removal was associated with moderate blood loss and blood transfusion. Magnesium has hypotensive effect and probably reduce intraoperative blood loss. Whether or not magnesium sulphate can reduce intraoperative blood loss and improve postoperative cognitive function is still inconclusive. So the investigators conduct the randomized control trial to compare the effect of magnesium with placebo control in blood loss and cognitive function in meningioma patient undergoing craniotomy.

NCT ID: NCT03520829 Recruiting - Brain Metastases Clinical Trials

Protocol for Evaluating a Planning Algorithm for Gamma Knife Radiosurgery

SPEED
Start date: January 10, 2018
Phase:
Study type: Observational

The process of developing Gamma Knife radiosurgery treatment plans is today very dependent on the level of human expertise resulting in a great heterogeneity of the intrinsic qualities of the treatment planning and the quality of care delivered in radiosurgery. The existing reverse planning systems, although they have progressed considerably in recent years, produce results that are still lower than those achieved by an expert. Conventionally, an experienced dosimetric planner will act mainly on the coordinates of the position of the isocenters, on the size of the collimators, sector by sector, and on the irradiation time of each isocenters. In theory, the combination of these variables provides access to billions of combinatorics whose diversity far exceeds the computational capabilities of the human mind. The dosimetric planner therefore uses a very small part of the spectrum of possible patterns by always reproducing a limited number of empirical solutions. The company Intuitive Therapeutics has developed a new mathematical algorithm which can automatically test in a very short time all the combinatorial possibilities and converge very quickly to the solution that best meets the clinical, anatomical and dosimetric objectives defined by the neurosurgeon. The quick processing of the system also allows the operator to modify the constraints to refine the proposed result in real time. The demonstration of the reality of the performances of this algorithm would give the ability to even inexperienced users to develop high performance planning for the benefit of the patient in terms of optimizing the efficacy / toxicity ratio of the radiosurgery treatment results The primary objective is to evaluate comparatively the quality of the schedules produced by the algorithm developed by the company Innovative Therapeutics to those produced by an expert who carried out more than 15000 dosimetric plannings and radiosurgical interventions. The main criterion of comparison is the Paddick index. The secondary criteria for comparison are: - Compliance index - selectivity index - Gradient index - Maximum, minimum, average dose at risk structures - Dose distribution in the target volume - Treatment time (at equal source activity) - Time of realization of the planning It was chosen to treat patients with vestibular Schwannoma OR multiple brain metastases (> 5) treated in single session by Gamma Knife OR para-optic meningioma in hypo-fractionated treatment on Gamma Knife with restraint mask with inclusion of visual paths in the target volume planning. The aim of the study is to show at least the non-inferiority of this new method compared to the expert user based on the Paddick Index. This index has continuous values between 0 and 1, 0 being the worst case and 1 being the ideal solution. In order to define the sample size needed for each pathology, a pilot phase is required. This phase can be performed retrospectively using treatments already defined by the expert user. This pilot phase will allow us to identify the difference that can be expected between the index values and the variability of this difference. Based on these values we will be able to determine the size of the sample allowing us to statistically test the non-inferiority, or even the superiority of this new device. The number of cases to be included during the pilot phase should be at least ten cases and a maximum of thirty cases. The choice of the number of cases to be integrated during this pilot phase will depend on the homogeneity of the differences obtained on the first cases. These values will allow us to calculate the size of the samples necessary for the study of non-inferiority as well as for the study of superiority. Depending on the calculated sizes samples we will make a choice to ensure that this study takes place in the expected duration.

NCT ID: NCT03462914 Not yet recruiting - Brain Neoplasms Clinical Trials

Comparative Study Between Different Approaches to CPA-petroclival Meningiomas

Start date: March 15, 2018
Phase: N/A
Study type: Observational [Patient Registry]

• Give an effective treatment for CPA-petroclival meningiomas and can detect the best approach for these tumors. . Improve the outcome of these patients and decease rate of recurrence.

NCT ID: NCT03434262 Completed - Neoplasms Clinical Trials

SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

Start date: March 5, 2018
Phase: Phase 1
Study type: Interventional

Approximately 90% of children with malignant brain tumors that have recurred or relapsed after receiving conventional therapy will die of disease. Despite this terrible and frustrating outcome, continued treatment of this population remains fundamental to improving cure rates. Studying this relapsed population will help unearth clues to why conventional therapy fails and how cancers continue to resist modern advances. Moreover, improvements in the treatment of this relapsed population will lead to improvements in upfront therapy and reduce the chance of relapse for all. Novel therapy and, more importantly, novel approaches are sorely needed. This trial proposes a new approach that evaluates rational combination therapies of novel agents based on tumor type and molecular characteristics of these diseases. The investigators hypothesize that the use of two predictably active drugs (a doublet) will increase the chance of clinical efficacy. The purpose of this trial is to perform a limited dose escalation study of multiple doublets to evaluate the safety and tolerability of these combinations followed by a small expansion cohort to detect preliminary efficacy. In addition, a more extensive and robust molecular analysis of all the participant samples will be performed as part of the trial such that we can refine the molecular classification and better inform on potential response to therapy. In this manner the tolerability of combinations can be evaluated on a small but relevant population and the chance of detecting antitumor activity is potentially increased. Furthermore, the goal of the complementary molecular characterization will be to eventually match the therapy with better predictive biomarkers. PRIMARY OBJECTIVES: - To determine the safety and tolerability and estimate the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of combination treatment by stratum. - To characterize the pharmacokinetics of combination treatment by stratum. SECONDARY OBJECTIVE: - To estimate the rate and duration of objective response and progression free survival (PFS) by stratum.

NCT ID: NCT03279692 Active, not recruiting - Clinical trials for High Grade Meningioma

Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma

Start date: November 7, 2017
Phase: Phase 2
Study type: Interventional

This research study is studying a drug as a possible treatment for High Grade Meningioma. The drug involved in this study is an immunotherapy drug called pembrolizumab

NCT ID: NCT03273712 Completed - Neuroblastoma Clinical Trials

Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)

Start date: September 29, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.

NCT ID: NCT03267836 Terminated - Meningioma Clinical Trials

Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma

Start date: January 10, 2018
Phase: Phase 1
Study type: Interventional

Meningioma 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