Clinical Trials for Brain Tumor

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.

HealthScout 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.

HealthScout 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.

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

A Randomized Surgical Window of Opportunity Study With Dose Escalation to Evaluate Whether Oral Fluoxetine Can Induce Cytotoxic Lysosomal Stress and Enhance Temozolomide Efficacy in Clinical 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.

HealthScout AI summary: Adults with recurrent malignant IDH–wildtype glioma eligible for repeat temozolomide and biopsy-to-delayed resection are randomized to preoperative temozolomide alone versus temozolomide plus fluoxetine (SSRI repurposed to induce cytotoxic lysosomal stress via lysosomal membrane disruption) with intraoperative pharmacodynamic assessment. Excludes patients on psychotropics or with psychiatric/seizure history and other QT/hyponatremia/comorbidity risks.

ClinicalTrials.gov ID: NCT05634707

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