Clinical Trials for Brain Tumor

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase I Dose-Escalation Study of Stereotactic Radiosurgery for Brain Metastasis Without Whole Brain Radiation

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.

HealthScout AI summary: Adults with non-hematologic cancers (excluding SCLC, germ cell, or unknown primary) and up to 10 non-brainstem brain mets ≤3 cm, radiation-naïve to the brain, receive single-fraction stereotactic radiosurgery alone with dose escalation to define the maximum tolerated dose. Prior systemic therapy and/or surgery allowed if at least one lesion remains for SRS; outcomes include safety within 90 days and local control/response, without whole-brain radiotherapy.

ClinicalTrials.gov ID: NCT02645487

Phase I/II Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

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.

HealthScout AI summary: Pediatric and young adult patients (<22 years) with relapsed/refractory intracranial gliomas (including GBM, anaplastic astrocytoma, oligodendroglioma, and radiographically diagnosed DIPG) receive monthly super-selective intra-arterial cerebral infusions of cetuximab (EGFR inhibitor) plus bevacizumab (VEGF-A inhibitor). Aims to enhance intratumoral delivery and assess safety and preliminary efficacy in measurable/evaluable disease with adequate performance status and organ function.

ClinicalTrials.gov ID: NCT05956821

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study

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.

HealthScout AI summary: Adults with non–small cell solid tumors (excluding SCLC/germ cell) and 1–10 brain metastases receive focal radiation via single-fraction SRS or hypofractionated SBRT (up to 3 fractions), selected by the treating team. The study focuses on neurocognitive outcomes, QoL, and intracranial control over 12 months; excludes leptomeningeal disease, recent brain surgery (<14 days), planned concurrent chemo with radiosurgery, and primary high-grade gliomas.

ClinicalTrials.gov ID: NCT03184038

Phase I/II Trial to Determine the Neurocognitive Decline in Patients With Multiple (>6) Brain Metastases Treated With Distributed Stereotactic Radiosurgery

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.

HealthScout AI summary: Adults with ≥6 brain metastases from solid tumors (including SCLC), no prior whole-brain radiotherapy, and ECOG 0–2/KPS ≥50–60 receive distributed stereotactic radiosurgery to all lesions (largest ≤4 cm) with hippocampal sparing. The study establishes the tolerated SRS dose and then evaluates neurocognitive outcomes (memory) and intracranial control.

ClinicalTrials.gov ID: NCT03508752

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions

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.

HealthScout AI summary: Adults with 1–3 brain metastases (≤3 cm; intact or post-resection) receive stereotactic radiosurgery planned with advanced DTI and volumetric MRI to spare eloquent white-matter tracts and bilateral hippocampi, aiming to reduce neurocognitive decline versus historical controls. Excludes prior WBRT, leptomeningeal disease, MRI contraindications, and certain histologies (germ cell, small cell, primary CNS lymphoma).

ClinicalTrials.gov ID: NCT04343157

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy 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.

HealthScout AI summary: Adults with solid tumor brain metastases (ECOG 0–1, no prior WBRT, no leptomeningeal disease) receive upfront pulsed reduced dose-rate whole-brain radiation therapy (30 Gy/10 fx) plus memantine to assess feasibility and explore neurocognitive outcomes versus historical WBRT. Prior SRS or resection and prior systemic therapy are allowed with washouts; excludes primary CNS/hematologic malignancies and large (>5 cm) unresected lesions.

ClinicalTrials.gov ID: NCT05045950