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Recurrent High-grade Glioma clinical trials

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NCT ID: NCT06305910 Recruiting - Clinical trials for Diffuse Midline Glioma, H3 K27M-Mutant

CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults

Start date: March 15, 2024
Phase: Phase 1
Study type: Interventional

This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults. The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG).

NCT ID: NCT06161610 Recruiting - Clinical trials for Recurrent High Grade Glioma

Recurrent High Grade Glioma Treated by LITT

REGALITT
Start date: September 19, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients. The main questions it aims to answer are: - The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments. - The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1. The intervention group patients will receive LITT. The control group will be treated with any other treatment. The primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.

NCT ID: NCT06126744 Not yet recruiting - Clinical trials for Recurrent High Grade Glioma

Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252

PuMP
Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.

NCT ID: NCT05737212 Recruiting - Clinical trials for Recurrent Glioblastoma

Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas

Start date: December 5, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-centered, radiation dose escalation, open, exploratory, Phase 1/2a clinical trial on the safety, efficacy and pharmacokinetic characteristics of BNCT in patients with recurrent high-grade gliomas. The Phase I clinical study is to explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas and characterize the safety, efficacy and pharmacokinetics. To evaluate the primary objective of tolerability, subject population with history of exposure to a similar treatment recurrent high-grade glioma who received prior standard radiotherapy will be recruited. The Phase IIa is to confirm the efficacy and safety after irradiation of radiation dose confirmed in the Phase I clinical study. To evaluate the primary objective of efficacy, subject population with glioblastoma (The 2021 WHO Classification of Tumors of the Central Nervous System, Glioblastoma IDH-wild type, WHO Grade 4) will be recruited.

NCT ID: NCT05698524 Recruiting - Glioblastoma Clinical Trials

A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma

Start date: June 26, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about treatment for a type of brain cancer called glioma. This clinical trial is for people with glioma who have been cancer-free for a period of time but their cancer has come back. The primary goals of this clinical trial are the following: - To determine the recommended dose of PCI-24781/Abexinostat with metronomic temozolomide - To evaluate side effects associated with using PCI-24781/Abexinostat with metronomic temozolomide

NCT ID: NCT05473923 Recruiting - Clinical trials for Recurrent High Grade Glioma

PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas

Start date: August 12, 2022
Phase: Early Phase 1
Study type: Interventional

This trial is an open-label, single-arm, phase 0/1 study of high-grade glioma that aims to evaluate the feasibility, preliminary efficacy and safety of the precision treatment strategy.

NCT ID: NCT05394558 Terminated - Clinical trials for Recurrent High-grade Glioma

AsiDNA Children, Adolescents and Young Adults

AsiDNA
Start date: May 27, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

HGG comprises diffuse midline gliomas (DMG), including diffuse infiltrating brainstem glioma (DIPG), characterised by histone gene mutations, as well as non-DM HGGs mainly in non-midline supratentorial areas, with distinct molecular abnormalities. First-line treatment comprises surgery when doable (non-DM HGGs), and radiotherapy in all cases. Chemotherapy or other drugs in clinical trials may be added during and/or after radiotherapy depending on the HGG subtype. The recurrence rate is nevertheless high in all paediatric and adolescent HGGs. If the time interval between the end of first-line radiotherapy and relapse is long enough, re-irradiation often provides good palliation of symptoms, delays disease progression, improves quality of life and has minimal and manageable toxicity. Nevertheless, strategies to increase efficacy without increasing toxicity in the treatment of recurrent paediatric HGG are much needed. AsiDNA™ is a DNA repair inhibitor that increases the vulnerability of tumour cells to irradiation without increasing toxicity in healthy tissues. Its novel mechanism of action, based on perturbation of the DNA damage recognition steps in DNA repair, makes its activity specific to tumour cells. Intravenous administration of AsiDNA is currently being investigated in adults with advanced solid tumours. The MTD was not reached during the escalating dose study on the safety, pharmacokinetics and pharmacodynamics of AsiDNA administered as a 1-hour infusion, however an optimal dose range (400-600 mg) was identified for further development, based on the favourable safety and PK profiles. Preclinical studies on AsiDNA added to radiotherapy have shown increased survival and no increase in short- or long-term toxicity due to the high doses of irradiation. The study will provide paediatric patients who have recurrent HGG with early access to innovation, even during the early drug development stage in adults.

NCT ID: NCT04822805 Recruiting - Clinical trials for Recurrent High-grade Glioma

A Study of Anlotinib in the Treatment of Recurrent High-grade Glioma

Start date: April 13, 2020
Phase: Phase 2
Study type: Interventional

This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of anlotinib in treatment of recurrent high-grade glioma.

NCT ID: NCT04588987 Recruiting - Neoadjuvant Therapy Clinical Trials

Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Start date: October 2020
Phase: Phase 2
Study type: Interventional

GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.

NCT ID: NCT03234595 Active, not recruiting - Clinical trials for Recurrent High Grade Glioma

A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma

Start date: November 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety and Efficacy Profile of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma. High grade gliomas, glioblastoma multiforme (grade IV) and anaplastic anaplastic astrocytoma (Grade III), are the most comment malignant brain tumor. The cause of gliomas remains unknown. Despite of several researches on environmental hazards and genetic alterations, no direct causes were found. Patient suffering from glioma usually develops symptoms such as headaches, seizures, memory loss and changes in behavior in its early phase. At later stages, patients may encounter loss of movement and sensation, language dysfunction and cognitive impairments depending on location and size of the tumor. The average survival of glioblastoma patients is 15 months regardless of the use of multimodal therapy. (Z)-BP/polymer wafer, designated as Cerebraca wafer, is a biodegradable wafer for interstitial implantation comprises (Z)-n-butylidenephthalide ((Z)-BP; the active moiety) and Carboxyphenoxypropane-Sebacic Acid Copolymer (CPPSA; the excipient). Cerebraca wafer, the first human-use drug product, is a biodegradable implant comprises (Z)-n-butylidenephthalide ((Z)-BP) and CPPSA. According to pre-clinical study, (Z)-BP could reduce glioma migration and invasion, it also could reduce the tumor stem cell marker gens.