Clinical Trials for Brain Tumor

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

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

ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients

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: Enrolls adults with recurrent/progressive IDH-mutant, 1p/19q co-deleted WHO grade 2–3 oligodendroglioma (≥12 weeks post-radiation, KPS ≥60) who can undergo resection/biopsy to confirm progression and provide tumor tissue, excluding those who previously progressed on an IDH1/2 inhibitor or have multifocal/leptomeningeal/infratentorial/extracranial spread or significant steroid dependence. Patients receive salvage IDH1/2 inhibitor therapy plus an individualized platform of autologous dendritic-cell vaccines pulsed with amplified total tumor RNA (broad antigen presentation) to prime immunity, followed by cyclophosphamide/fludarabine lymphodepletion and a single infusion of ex vivo expanded autologous tumor-reactive T cells with autologous CD34+ stem-cell support.

ClinicalTrials.gov ID: NCT06254326

A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression

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: Enrolls adults with locally advanced/metastatic/unresectable solid tumors harboring ERBB2 (HER2) activating alterations, NRG1 fusions, or HER2 overexpression, with expansion cohorts for ERBB2-mutant NSCLC with brain metastases and ERBB2-mutant or HER2-overexpressing breast cancer with brain metastases ± leptomeningeal disease. Patients receive oral CGT4255, an investigational EGFR-sparing selective HER2 tyrosine kinase inhibitor designed to cover multiple oncogenic HER2 mutations with CNS penetration, given at escalating/selected doses.

ClinicalTrials.gov ID: NCT07361562

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

A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

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: For pediatric and adult patients with relapsed/refractory high-risk neuroblastoma/ganglioneuroblastoma or osteosarcoma, after standard therapies. Patients receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous GD2-directed CAR T cells engineered to co-express IL-15 (to enhance persistence/function) and an inducible caspase-9 safety switch.

ClinicalTrials.gov ID: NCT03721068

A Phase I, Multicentre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD1390 in Combination With Radiation Therapy in Patients With Glioblastoma Multiforme and Brain Metastases From Solid Tumors.

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 CNS tumors receiving radiotherapy: recurrent/relapsed GBM (IMRT 35 Gy/2 weeks) and newly diagnosed GBM with unmethylated MGMT (IMRT 60 Gy/6 weeks) are treated with concurrent oral AZD1390, a brain-penetrant ATM kinase inhibitor radiosensitizer; the closed arm previously enrolled patients with brain metastases not suitable for SRS. Key eligibility includes KPS ≥60 and MRI suitability; exclusions include strong CYP3A4 modulators and significant comorbidities.

ClinicalTrials.gov ID: NCT03423628