Clinical Trials for Brain Tumor

Phase I Study of Stereotactic Radiosurgery Dose Escalation for Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 1–5 previously unirradiated, non–brainstem brain metastases (KPS ≥60) receive stereotactic radiosurgery with dose escalation to one or more eligible lesions, while other lesions (if present) receive standard SRS dosing. Excludes radiosensitive primaries (e.g., small cell, germ cell, lymphoma/leukemia, myeloma) and leptomeningeal disease; evaluates safety/MTD based on grade ≥3 toxicities over 12 weeks.

ClinicalTrials.gov ID: NCT02390518

A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 5–15 brain metastases (non-hematologic primaries; largest lesion <2.5 cm; ECOG 0–2) are randomized to stereotactic radiosurgery to all lesions versus hippocampal-avoidant whole-brain radiotherapy plus memantine (an NMDA receptor antagonist to mitigate cognitive decline). Excludes prior cranial RT, leptomeningeal disease, lesions near the optic apparatus, certain histologies (germ cell, small cell, lymphoma), and >15 lesions on volumetric MRI.

ClinicalTrials.gov ID: NCT03550391

Feasibility of Evaluating Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

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 aged 18–39 with recurrent high-grade glioma, including diffuse midline glioma, receive short-course preoperative abemaciclib (oral CDK4/6 inhibitor) followed by surgery with intratumoral microdialysis to measure CNS penetration; those meeting PK/PD thresholds may continue abemaciclib 150 mg BID with temozolomide in 28-day cycles. Excludes prior CDK4/6 inhibitor exposure and patients unable to safely undergo biopsy or on strong/moderate CYP3A modulators.

ClinicalTrials.gov ID: NCT05413304

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.

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.

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 Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 measurable brain metastases from TNBC, NSCLC without actionable drivers, or other PD‑1/anti‑angiogenic–sensitive solid tumors (asymptomatic/minimally symptomatic, ECOG 0–1) receive pembrolizumab (PD‑1 inhibitor) plus lenvatinib (VEGFR/FGFR/PDGFR/RET/KIT multikinase inhibitor). Focus is on intracranial efficacy with allowances for untreated or post-radiation progressing brain lesions; excludes leptomeningeal disease and NSCLC with EGFR/ALK/ROS1/RET/NTRK/BRAF V600E/MET alterations.

ClinicalTrials.gov ID: NCT05064280

A Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors

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 (12–25 years) with recurrent or refractory brain tumors of any histology, requiring available tumor tissue for sequencing to design a personalized neoantigen DNA vaccine. Treatment is an intramuscular, electroporation-delivered DNA vaccine encoding patient-specific tumor neoepitopes to induce T-cell responses, given monthly for six priming doses then quarterly boosters.

ClinicalTrials.gov ID: NCT03988283

Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 solid tumor brain metastases requiring whole-brain radiotherapy (no prior WBRT; memantine-naïve; KPS ≥70) receive normal tissue sparing WBRT with optional simultaneous integrated boost plus concurrent memantine to preserve quality of life and neurocognition while maintaining intracranial control. Prior SRS/craniotomy/partial brain RT allowed; excludes leptomeningeal disease.

ClinicalTrials.gov ID: NCT05013892

BrainMet ADePPT (Anticancer Drug Penetration Platform 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.

TrialFetch AI summary: Adults with KRAS G12C–mutant brain tumors requiring neurosurgical resection/biopsy (including those with prior CNS radiation/systemic therapy and optional leptomeningeal disease) receive oral sotorasib, either standard dose if DCOI-naïve or continued at prior dose if previously treated. Sotorasib is a selective covalent KRAS G12C inhibitor that locks KRAS in the inactive GDP-bound state; the trial assesses intracranial drug penetration, safety, and preliminary efficacy around the perioperative period.

ClinicalTrials.gov ID: NCT06807619

Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 extracranial primary cancer and at least one intact 2.0–4.0 cm brain metastasis (no prior WBRT, no large brainstem lesions, no leptomeningeal disease) are randomized to single-fraction SRS versus fractionated SRS delivered on Gamma Knife or LINAC. The trial compares local control plus symptomatic radiation necrosis risk (composite endpoint), with secondary outcomes including OS, CNS failure patterns, neurologic death, toxicity, and PROs.

ClinicalTrials.gov ID: NCT05222620