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A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)

Primary objective:To determine the MTD/recommended dose for further study of oral LOXO-292 in patients with advanced solid tumors, including RET-fusion NSCLC, MTC, and other tumors with increased RET activity.Secondary objectives:* To determine the…

The SAFE-trial: Safe Surgery for Glioblastoma Multiforme: Awake Craniotomy versus Surgery under General Anesthesia. A multicenter prospective randomised controlled study

The study will take place in 5 neurosurgical centers in the Netherlands (Erasmus MC, UMC Utrecht, Elizabeth Ziekenhuis Tilburg, MC Haaglanden The Hague, UMCG Groningen) and one center in Belgium (UZ Gent). All centers have ample experience with the…

Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

This exploratory study is designed to evaluate several depatuxizumab mafodotin-related OSE management strategies.The main objective of this trial is to estimate the percentage of subjects in each prophylactic treatment arm who require a change in…

18F-PSMA PET/CT for visualization of glioblastoma multiforme

Primary objective: * Determine the feasibility of using 18F-PSMA PET/CT for visualization of GBM.Secondary objectives:* Correlate PSMA RNA and protein expression with 18F-PSMA PET/CT uptake.

RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence

Overall ObjectiveThe purpose of the study is to compare the effect of craniotomy and tumor resection followed by adjuvant second-line therapy to no surgery followed by second-line therapy on overall survival, neurological status, and quality of life…

Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients with Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study (STEAM)

- to determine the recommended phase 2 dose of TG02 in combination with radiotherapy in older patients (>65 years of age) with IDHwt glioblastoma and anaplastic astrocytoma without MGMT promoter methylation- to determine the recommended phase…

Seizure Treatment IN Glioma (STING): comparing a treatment strategy with levetiracetam versus treatment with valproic acid in glioma patients with a first seizure

The overall aim of this strategy study is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with de novo seizures. In addition, we aim to examine the level of toxicity, the impact of seizures…

Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in childeren and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

This study aims to demonstrate the effectiveness of dabrafenib with trametinib in pediatric patients with BRAF V600 mutant relapsed refractory HGG.This study aims to demonstrate the effectiveness of dabrafenib with trametinib compared to…

International Multicenter Phase I trial of Hydroxyurea in Combination with Dose-Intense Temozolomide in Recurrent Glioblastoma.

This is a phase I study of hydroxyurea and dose-intense temozolomide in patients with recurrent glioblastoma that are elegise for re-challenge temozolomide.Primary Objective: To determine the maximal tolerated dose and safety profile of daily…

Early prediction of Glioma Recurrence to Radiotherapy by 31P MRS and 1H CEST MRI

To non-invasively measure metabolic alterations in GBM with 31P MRS at 7T and CEST MRI at 3T and 7T before and after radiotherapy (after the first session and after the whole treatment), and compare these results with Cx30 levels obtained from pre-…

Visual impairment in children with a brain tumor in the Netherlands: a prospective nationwide study using standard visual testing and optical coherence tomography

Primary objective:To study whether changes in OCT parameters lead to earlier detection of visual decline compared to standard ophthalmological testing (visual field, visual acuity) in children with a brain tumor. Secondary objective: To study the…

A multi-centre, open-label, single-arm, dose-finding phase I/II study to evaluate safety, tolerability, dosing schedule, and preliminary efficacy of carrier-added 4-L-[131I]iodo-phenylalanine (131I-IPA), administered as single or repetitive injections in patients with recurrent glioblastoma multiforme (GBM), concomitantly to 2nd line external radiation therapy (XRT) - IPAX-1Study

Primary objectiveTo assess the safety and tolerability of intravenous 131I-IPA administered concomitantly to 2nd line XRT in recurrent GBMSecondary objectives:- To assess the maximum tolerated dose (MTD) of 131I -IPA administered concomitantly to…

Image guidance in neurosurgery: Flatpanel-Detector Parenchymal Blood Volume imaging and Magnetic Resonance - Dynamic Contrast Enhanced perfusion imaging in meningiomas

The primary objective of this clinical pilot study is to explore the feasibility of Flatpanel Detector - Parenchymal Blood Volume (FD-PBV) imaging in patients with intracranial meningiomas during neurosurgery in the Hybrid-OR. Image quality, added…

An international multicenter phase II randomised trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy

Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…

PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA

Primary:• Phase I part: to define the recommended dose (RD) of nilotinib and vinblastine when used in combination• Phase II part: to evaluate the efficacy of vinblastine in combination with nilotinib (VINILO) at the RD, as compared to vinblastine…

11C-erlotinib brain uptake in Diffuse Intrinsic Pontine Glioma imaged by PET

Primary objective:Non-invasively determining the 11C-erlotinib brain uptake in DIPG patients by PET imaging.Secondary objective:Determining the EGFR expression in DIPG

INTELLANCE 2: ABT-414 alone or ABT-414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumor Group

The objectives of the trial are to assess whether ABT-414 alone or in combination with TMZ improves overall survival (OS), PFS, tumor response, quality of life, NDFS and steroid use compared to standard treatment with lomustine single agent or TMZ…

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

The primary objective of this study is to demonstrate superiority in overall survival (OS) and comparable safety when eflornithineis added to lomustine compared to lomustine alone in patients with anaplastic astrocytoma (AA) that progress/recur…

The function and composition of B cells in patients with Glioblastoma treated with and without Dexamethasone

Identify if dexamethasone treatment alters the frequency and functionality of atypic B cells in blood.

Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies

Firstly, the objective of the study is to estimate the safety and tolerability of study treatments (firstly nivolumab alone, and then nivolumab in combination with ipilimumab) in pediatric participants with primary high-grade CNS tumors.Secondly,…