Clinical Trials for Brain Tumor

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)

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.

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.

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

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.

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.

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

Phase I/II Study of Laser Interstitial Thermotherapy (LITT) Combined With Checkpoint Inhibitor for Recurrent GBM (RGBM)

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.

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.

TrialFetch AI summary: Adults with recurrent supratentorial glioblastoma or gliosarcoma after standard chemoradiation, with unifocal/unilateral disease suitable for LITT (≤6 cm), receive stereotactic biopsy and LITT plus pembrolizumab (anti–PD‑1) given either 7 days before or 14/35 days after LITT, then every 3 weeks. Excludes prior PD‑1/PD‑L1 therapy and active autoimmune disease; aims to define optimal sequencing and assess antitumor activity versus historical controls.

ClinicalTrials.gov ID: NCT03277638

Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

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.

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.

TrialFetch AI summary: Adults with newly diagnosed, EGFR-overexpressing glioblastoma receive super-selective intra-arterial cetuximab after mannitol blood–brain barrier disruption at set postoperative intervals, in addition to standard Stupp chemoradiation. Cetuximab is an anti-EGFR IgG1 monoclonal antibody that blocks EGFR signaling and may mediate ADCC.

ClinicalTrials.gov ID: NCT02861898

Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma.

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.

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.

TrialFetch AI summary: Adults with relapsed/refractory high-grade glioma (GBM, anaplastic astrocytoma/oligoastrocytoma), KPS ≥70, receive super-selective intraarterial bevacizumab 15 mg/kg after osmotic BBB disruption with IA mannitol, repeated at progression. One arm also adds standard biweekly IV bevacizumab 10 mg/kg between IA treatments; bevacizumab is an anti–VEGF-A monoclonal antibody inhibiting angiogenesis.

ClinicalTrials.gov ID: NCT01269853

RNA PRIME - RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

TrialFetch AI summary: Pediatric and young adult patients with recurrent/progressive high-grade glioma (excluding DIPG) ages 3–25 or osteosarcoma ages 3–39 (pulmonary-only recurrence or unresectable disease) receive an intravenous two-step RNA–lipid particle vaccine program: an off‑the‑shelf CMV pp65/LAMP primer (DP1) followed by a personalized product (DP2) combining pp65 with autologous tumor mRNA. The investigational RNA–LPs aim to activate innate sensors (e.g., RIG‑I) and antigen-presenting cells to broaden antitumor T‑cell responses; dosing is given every ~2 weeks during priming and early DP2, then monthly maintenance.

ClinicalTrials.gov ID: NCT05660408

Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

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.

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.

TrialFetch AI summary: Adults with recurrent WHO grade IV glioblastoma planned for repeat resection and re-irradiation receive neoadjuvant pembrolizumab (anti–PD-1 monoclonal antibody) combined with stereotactic radiation therapy, followed by surgery. Key exclusions include prior checkpoint inhibitor therapy, contraindication to re-irradiation, significant immunosuppression, or pembrolizumab hypersensitivity.

ClinicalTrials.gov ID: NCT04977375

Phase I Clinical Trial of GPC2 Chimeric Antigen Receptor T (GPC2-CAR T) Cells for Relapsed or Refractory Medulloblastoma in Children and Young Adults

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

TrialFetch AI summary: Children and young adults (12 months–30 years) with GPC2-positive relapsed/refractory medulloblastoma or other eligible CNS embryonal tumors receive autologous GPC2-directed CAR T cells via intracerebroventricular infusions after fludarabine/cyclophosphamide lymphodepletion. GPC2-CAR T targets glypican-2 (oncofetal heparan sulfate proteoglycan) with locoregional delivery and intrapatient dose escalation over up to 8 cycles.

ClinicalTrials.gov ID: NCT07087002

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

TrialFetch AI summary: Adults with recurrent or rare primary CNS tumors (e.g., GBM, diffuse midline glioma, ependymoma, medulloblastoma, atypical/anaplastic meningioma) after standard therapy receive oral ONC206 monotherapy. ONC206 is an imipridone that non-competitively antagonizes DRD2/DRD3 and allosterically hyperactivates mitochondrial ClpP, aiming to trigger integrated stress response and apoptosis; dose-escalation with food-effect/PK assessment and potential expansion at RP2D.

ClinicalTrials.gov ID: NCT04541082

A Phase 1/2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

TrialFetch AI summary: Pediatric patients (12 months–21 years) with relapsed/refractory solid tumors or lymphoma, including CNS tumors; Phase 2 focuses on progressive/recurrent DIPG or other H3 K27–altered diffuse midline gliomas post-radiation. Single-arm IV CBL0137 (a FACT “chromatin-trapping” agent that activates p53, suppresses NF-κB, and induces interferon response) is given on Days 1 and 8 of 21-day cycles to define RP2D and assess antitumor activity.

ClinicalTrials.gov ID: NCT04870944