Clinical Trials for Brain Tumor

Phase I Study of Intraventricular Infusion of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) in Subjects With Recurrent or Refractory Glioblastoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent or refractory glioblastoma (supratentorial or infratentorial) post-surgery/biopsy and ≥40.05 Gy RT with concurrent temozolomide, KPS >60%, and no prior anti-angiogenic or CAR T therapy receive up to three weekly intraventricular infusions of autologous CAR T cells targeting B7-H3 (CD276). Therapy is delivered via the ventricular system to enhance CNS distribution; study focuses on safety, CRS/neurotoxicity, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT05366179

A Feasibility Study Examining the Use of Non-Invasive Focused Ultrasound (FUS) With Oral Etoposide Administration in Children With Progressive Diffuse Midline Glioma (DMG)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Children and young adults (4–21) with progressive diffuse midline glioma of the pons and/or thalamus (including H3K27M-mutant) receive non-invasive focused ultrasound with microbubbles and neuronavigation to transiently open the BBB at tumor-adjacent sites, combined with concurrent oral etoposide (topoisomerase II inhibitor). Key exclusions include prior etoposide, implanted devices, uncontrolled seizures, significant cardiac/QTc issues, coagulopathy/anticoagulation, and inability to tolerate MRI/anesthesia.

ClinicalTrials.gov ID: NCT05762419

Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent WHO grade IV GBM undergoing planned ≥80% re-resection receive a laparoscopically harvested autologous omental tissue graft lining the resection cavity to bypass the BBB and potentially enhance local delivery/trafficking of therapeutics and immune cells. Single-arm safety study; excludes multifocal/leptomeningeal disease and patients unable to safely undergo omentum harvest.

ClinicalTrials.gov ID: NCT05979064

Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent/refractory EGFR-overexpressing high-grade gliomas (GBM, anaplastic astrocytoma/oligoastrocytoma) after Stupp protocol receive superselective intra-arterial cetuximab following mannitol BBB disruption plus hypofractionated re-irradiation. Cetuximab is an anti-EGFR IgG1 monoclonal antibody that blocks EGFR signaling and mediates ADCC; eligibility requires measurable disease and KPS ≥60%.

ClinicalTrials.gov ID: NCT02800486

REMASTer: REcurrent Brain Metastases After SRS Trial

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with a single brain metastasis showing radiographic progression after prior SRS are randomized via an intraoperative pathology–guided algorithm to LITT (NeuroBlate MRI-guided thermal ablation) with or without hypofractionated re-irradiation if recurrent tumor, or to LITT plus steroids versus steroids alone if radiation necrosis. Designed to test local control after ablation in true recurrence and time to steroid independence in radiation necrosis.

ClinicalTrials.gov ID: NCT05124912

Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With GD2-expressing Brain Tumors (GAIL-B)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Pediatric and young adult patients (12 months–22 years) with GD2-expressing CNS tumors—including diffuse midline glioma/high-grade glioma and select other high-grade brain tumors—receive lymphodepletion (cyclophosphamide/fludarabine) followed by autologous GD2-directed CAR T cells engineered with a constitutively active IL‑7 receptor (C7R) to enhance persistence. Cohort 1 gets initial IV CAR T then intracerebroventricular dosing via Ommaya/VP shunt; Cohort 2 (recurrent/progressive pontine HGG or H3K27-altered DMG) receives IV only.

ClinicalTrials.gov ID: NCT04099797

SJ901: Phase 1/2 Evaluation of Single Agent Mirdametinib (PD-0325901), a Brain-Penetrant MEK1/2 Inhibitor, for the Treatment of Children, Adolescents, and Young Adults With Low-Grade Glioma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Enrolling patients aged 2 to <25 years with centrally confirmed MAPK-activated WHO grade I–II pediatric low-grade glioma (including eligible glioneuronal/neuroepithelial tumors), across newly diagnosed and recurrent/progressive settings, with measurable/evaluable disease; excludes BRAF V600, NTRK/ALK/ROS1 fusions, IDH1/2, and significant ocular/cardiac/hepatic/pulmonary comorbidity. Investigational therapy is oral single-agent mirdametinib, a selective brain-penetrant MEK1/2 inhibitor targeting MAPK/ERK signaling, given BID in 28-day cycles; cohorts include MEK inhibitor–naïve and previously MEK-exposed patients.

ClinicalTrials.gov ID: NCT04923126

A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent high-grade glioma (IDH-mutant grade 3/4 astrocytoma or IDH-wildtype glioblastoma) after standard therapy, with tumors suitable for convection-enhanced delivery and meeting RANO progression and performance criteria. Single intratumoral infusion of 186Rhenium nanoliposomes via CED, a beta-emitting radiotherapeutic encapsulated in nanoliposomes to deliver localized high-dose radiation with imageable distribution (SPECT); excludes multifocal/leptomeningeal disease, infratentorial tumors, recent bevacizumab or radiation, and lesions risking ventricular/subarachnoid leak.

ClinicalTrials.gov ID: NCT01906385

A Phase 0/1 Pharmacokinetic and Pharmacodynamics and Safety and Tolerability Study of Letrozole in Combination With Standard Therapy in Recurrent High Grade Gliomas

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent high-grade glioma (ECOG 0–2) receive oral letrozole, an aromatase inhibitor aimed at achieving brain/tumor penetration, with the expansion cohort treating with letrozole 15 mg daily plus metronomic temozolomide 50 mg/m2 daily. Initial cohorts required planned resection/biopsy for PK assessment; the expansion enrolls patients with measurable recurrence without a surgery requirement.

ClinicalTrials.gov ID: NCT03122197

A Phase I/II Study of Ex-Vivo Expanded Allogeneic Universal Donor (UD) TGFbi NK Cell Infusions in Combination With Temozolomide as a Lymphodepleting Agent in Patients With Melanoma Metastatic to the Brain

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with progressive melanoma brain metastases (measurable ≥10 mm, ECOG 0–2) receive temozolomide lymphodepletion followed by IV infusions of ex vivo–expanded allogeneic TGF-β–inhibited NK cells, which are designed to resist TGF-β–mediated immunosuppression and enhance NK cytotoxicity in the CNS. Key exclusions include leptomeningeal disease and need for immediate stereotactic radiotherapy; corticosteroids allowed if stable/minimal.

ClinicalTrials.gov ID: NCT05588453