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Glioblastoma Multiforme clinical trials

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NCT ID: NCT05402241 Completed - Clinical trials for Glioblastoma Multiforme

IRD at Admission Predicts Survival of GBM Patients - a Prospective Pilot Study

IRD-GBM
Start date: October 21, 2021
Phase:
Study type: Observational

Glioblastomas (GBM) are the most common primary malignant brain tumor with a very high recurrence rate and an average survival of 14 months. Identifying an imaging biomarker to predict recurrence is critical. Using a special MRI technique called diffusion weighted imaging (DWI), a recent retrospective study described isolated restricted diffusion (IRD) foci. The presence of IRD was found in 40% of patients with GBM on index imaging and was associated with longer survival. IRD foci are not currently identified as having a tumor focus and are not included in treatment strategies and guidelines. These findings need to be confirmed in a prospective study. The investigators propose a prospective pilot study to establish the incidence of IRD on the index imaging of patients with GBM. The investigators will collect surgical samples from these foci to establish the histological and molecular signature to confirm GBM in these newly identified foci. The results from this pilot study will guide the planning of a larger well powered multicenter study that will help establish IRD as an imaging biomarker in the GBM management guidelines, which will help improve the outcomes in patients with GBM.

NCT ID: NCT04810182 Completed - Clinical trials for Glioblastoma Multiforme

Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS

Start date: September 10, 2020
Phase:
Study type: Observational

This study aims to analyze the role the of Regorafenib in prolonging the Overall Survival of glioblastoma multiforme patients who progressed after surgery and a first-line chemo-radiotherapy treatment in the setting of "real world life".

NCT ID: NCT04790097 Completed - Clinical trials for Glioblastoma Multiforme

FET-PET Directed Simultaneous In-field Boost for Primary GBM

dualFETboost
Start date: February 21, 2017
Phase: N/A
Study type: Interventional

The combination of anatomical MRI examination with functional examination of tissue metabolic activity such as FET-PET (PET using the radiotracer - 18F-fluoro-ethyl-tyrosine) is a valuable tool to determine the actual tumor infiltration. The FET-PET examination can be performed using the dual-time point aqusition of FET for exact treatment planning. It has also been proven that using the dual FET-PET method, it is possible to obtain a precise image of the glioblastoma infiltration corresponding to the location and shape of the recurrence, and the tumor volumes in dual FET-PET are significantly larger than in MRI. Moreover, tumor defined in dual FET-PET is different than that of the tumor defined in single FET-PET acquisition. In the DualFETboosT trial we plan to assess the safety and preliminary efficacy of hypofractionated irraditon using simultaneous in-field boost directed on dual FET-PET based tumor volumes for treatment of primary glioblastoma multiforme with concomitant temozolomide.

NCT ID: NCT04610229 Completed - Glioblastoma Clinical Trials

Safety of IMRT Treatment With Inhomogeneous Dose in Patients With Relapsed High-grade Gliomas.

GLIORAD
Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Relapsed GBMs have a life expectancy of a few months and re-radiation has proven to be safe in terms of toxicity and effective in increasing OS. One of our studies [Ciammella P, 2013, 8:222] reported a median survival of 9.5 months in patients with recurrent GBM and treated with stereotactic radiotherapy with a total dose of 25 Gy in 5 consecutive sessions, in which the dose was prescribed to 70% isodose with a homogeneous gradient towards the center of the target volume. The identification with functional imaging of specific areas with higher tumor cell density, and the possibility of delivering precisely, thanks to the most advanced therapy units, different doses to the different sub-volumes, can lead to an increase in the maximum dose that can be delivered at the expense of the most aggressive areas (with a greater effect on the tumor), compared to smaller doses in areas with lower signal alteration. This selectivity of the doses should allow an increase in the efficacy of the therapy and therefore a hypothetical increase in local control, compared to a radio-induced toxicity on the surrounding healthy tissues almost comparable to that achieved with the previous hypofractionated treatments [Ciammella P, 2013]. In fact, delivering many high doses to the entire volume would result in an excess of radio-induced necrosis within the irradiated regions with high dose, as well as the impossibility of minimizing the doses on healthy areas and / or on non-neoplastic critical areas keeping them at internal dose ranges related to minimal and acceptable toxicity levels. Since there are no studies providing clear indications on the acute and late toxicity of irradiated healthy tissues that have already been the subject of a first course of radiotherapy (STUPP), the choice of safety is the primary objective of the study.

NCT ID: NCT04446416 Completed - Neoplasms Clinical Trials

Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients

Start date: July 21, 2020
Phase: N/A
Study type: Interventional

This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients. The BEV is the best physician's choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial Hospital. Eligible patients will be enrolled through the process of informed consent.

NCT ID: NCT04444427 Completed - Clinical trials for Non-small Cell Lung Cancer

Evaluation of GLR2007 for Advanced Solid Tumors

Start date: July 15, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Evaluation of GLR2007 for Advanced Solid Tumors

NCT ID: NCT03849105 Completed - Clinical trials for Glioblastoma Multiforme

131I-IPA and Concurrent XRT in Recurrent GBM

IPAX-1
Start date: April 9, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

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-1

NCT ID: NCT03834740 Completed - Clinical trials for Glioblastoma Multiforme

A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection

Start date: December 21, 2018
Phase: Early Phase 1
Study type: Interventional

In the proposed trial, patients will be administered ribociclib+everolimus prior to surgical resection of their tumor. Recurrent GBM patients will be randomized into one of the three time-interval cohorts for the first two dose levels. In the lead-in dose escalation study, the first six subjects (lead-in) will receive ribociclib 400 mg and everolimus 2.5 mg orally-administered in 5 daily doses with the last dose. If one or less patient experiences DLT among the 6 patients, this regimen with ribociclib 400 mg and everolimus 2.5mg will be considered safe and we will continue with the dose escalation phase of the study up to Level 3. Four dose escalation levels: Level 0: ribociclib 400mg and everolimus 2.5 Level 1: ribociclib 600mg and everolimus 2.5mg Level 2: ribociclib 600mg and everolimus 5mg Level 3: ribociclib 600mg and everolimus 10mg

NCT ID: NCT03722355 Completed - Glioma Clinical Trials

Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma

Start date: November 9, 1990
Phase: Phase 3
Study type: Interventional

Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.

NCT ID: NCT03712293 Completed - Clinical trials for Glioblastoma Multiforme

ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy

Start date: August 28, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with Glioblastoma undergoing standard of care therapy.