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Astrocytoma, Grade IV clinical trials

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NCT ID: NCT06161974 Not yet recruiting - High Grade Glioma Clinical Trials

Study of Olutasidenib and Temozolomide in HGG

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.

NCT ID: NCT06157541 Recruiting - Clinical trials for Glioblastoma Multiforme

T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

TCaP
Start date: February 8, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus [CMV]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4. Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.

NCT ID: NCT06118723 Recruiting - Glioblastoma Clinical Trials

The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)

SUPRAMAX
Start date: January 1, 2022
Phase:
Study type: Observational

A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).

NCT ID: NCT06017063 Not yet recruiting - Glioblastoma Clinical Trials

Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields

COCOON
Start date: October 2023
Phase: N/A
Study type: Interventional

The aim is to improve patients' compliance to TTFields therapy by a psychological video intervention in a multi-center, randomized controlled trial.

NCT ID: NCT05375318 Recruiting - Glioblastoma Clinical Trials

BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, Cellular, and Histopathological Levels

BIOhabitats
Start date: March 1, 2021
Phase:
Study type: Observational

The main purposes of this study are: I. To assess that the four habitats within the tumor (HAT and LAT) and edema (IPE and VPE) in high-grade glioma are different at vascular, tissular, cellular and molecular levels. II. To analyze the associations between the perfusion imaging markers and relevant molecular markers at the HTS habitats for high-grade glioma diagnosis, prognosis/aggressiveness, progression and/or prediction. III. To analyze the associations between the perfusion imaging markers and immune markers at the HTS habitats useful in immunotherapy evaluation and/or patient selection. IV. To prospectively validate the prognostic capacity (association with OS and PFS) and stratification capacity of the perfusion imaging markers calculated at the HTS habitats.

NCT ID: NCT05229198 Recruiting - Clinical trials for Astrocytoma, Grade IV

ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas

ALBATROSS
Start date: June 1, 2020
Phase:
Study type: Observational

This Clinical study is framed in the ALBATROSS Project: Clinically validated decision support system based on pixel level Artificial Intelligent models for deciding treatment in glioblastoma. The prospective multicenter international dataset compiled during the ALBATROSS project will include a cohort up to 300 new patients diagnosed with GB after June 1, 2020. Longitudinal images (T1, T2, T1c, FLAIR, PWI-DSC and DWI at least), complete molecular profiling, primary and secondary lines of treatment and clinical conditions will be included for each patient.

NCT ID: NCT05218408 Withdrawn - Glioblastoma Clinical Trials

CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type

CYNK001GBM02
Start date: March 8, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2a Open Label Multicenter, Non-Randomized, Trial to Assess the Safety and Efficacy of CYNK-001 in Combination with Recombinant Human Interleukin-2 in Adults with Recurrent Resection Eligible IDH1 wild-type Glioblastoma. For phase I portion, the study objectives to assess the safety and feasibility CYNK-001 in combination with rhIL2 of Intravenous (IV) infusion and Intracavitary (IC) administrations following tumor resection and to establish a maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D) for IV and IC CYNK-001 administration. For Phase IIa, to evaluate efficacy and safety of CYNK-001 administrations in recurrent GBM as measured by Progression Free Survival at 6 months (PFS6M)

NCT ID: NCT04757662 Completed - Clinical trials for Astrocytoma, Grade IV

Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma

Start date: May 14, 2021
Phase: Phase 1
Study type: Interventional

Increasing preclinical and clinical data have shown that myeloid-derived suppressor cells (MDSCs) may represent a significant driver of immunosuppression in glioblastoma (GBM, grade IV astrocytoma) and a potential mechanism of treatment resistance to chemoradiotherapy. Tadalafil, an FDA-approved drug with inexpensive cost and excellent safety profile, has been shown to effectively reduce MDSCs and restore T-cell activation in the peripheral blood and in the tumor microenvironment. The purpose of this study is to investigate the impact of targeting MDSCs in newly diagnosed IDH-wildtype grade III-IV astrocytoma by combining tadalafil with standard of care radiation therapy (RT) and temozolomide (TMZ).

NCT ID: NCT04489420 Terminated - Clinical trials for Glioblastoma Multiforme

Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM

CYNK001GBM01
Start date: October 1, 2020
Phase: Phase 1
Study type: Interventional

This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy for the systemic cohort (IV) (intravenous). The intratumoral cohort (IT) will not be giving lymphodepletion. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating recurrent glioblastoma multiforme.

NCT ID: NCT03956706 Withdrawn - Glioblastoma Clinical Trials

Study of Stereotactic Radiosurgery to the Subventricular Zone in Malignant Gliomas

Start date: December 24, 2018
Phase: N/A
Study type: Interventional

Several investigations suggest neural stem cells located in the subventricular region play an active role in promoting or even initiating cortical malignant glioma growth. Although normal appearing on neuroimaging, surgical specimens taken from this region show it contains malignant glioma stem-like cells. Some retrospective analyses found patients who received radiation therapy to this region during standard of care treatments lived longer than patients who did not. The investigator's study hypothesizes (1) stereotactic radiosurgery of cancer stem-like cells in these regions will be well tolerated during standard of care therapy, (2) focused stereotactic radiosurgery will be more effective in destroying cancer stem cells than conventional radiation therapy, and (3) treatment will improve malignant glioma survival.