Clinical Trials for Brain Tumor

Pilot Trial of Spectroscopic MRI-guided, Dose-Escalated Proton Radiation Therapy and Bevacizumab for Recurrent Glioblastoma

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 recurrent glioblastoma or gliosarcoma after prior standard brain RT (≤63 Gy), ECOG 0–2, single measurable lesion ≤6 cm, receive spectroscopic MRI-guided focal proton re-irradiation (IMPT, 35 Gy/10 fx or 40 Gy/10 fx with SIB) combined with bevacizumab (anti–VEGF-A monoclonal antibody) started before RT. Excludes multifocal disease, prior re-irradiation or bevacizumab, and lesions in regions prone to sMRI artifact.

ClinicalTrials.gov ID: NCT05284643

Surgical Resection of Latent Brain Tumors Prior to Recurrence

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 residual or previously unresected brain tumors after prior chemo/radiation and visible latent disease on imaging undergo clinically indicated pre-recurrence surgical resection, with standard perioperative care and imaging surveillance. Correlative studies include tissue/CSF/blood profiling (including comparison of radiated vs non-radiated tissue and ex vivo sensitivity testing), and outcomes include safety, neurosurgical morbidity, and survival.

ClinicalTrials.gov ID: NCT04810871

A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease

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 1–4 resectable brain metastases (≤4 cm) from solid tumors (RPA I–III, KPS ≥60) are randomized intraoperatively to local chemotherapy with GLIADEL carmustine (BCNU) wafers placed in the resection cavity versus standard postoperative stereotactic radiosurgery to the cavity; remaining lesions (up to three) receive SRS. GLIADEL delivers high local concentrations of the alkylating agent BCNU (DNA crosslinker), and the trial compares local control at 12 months, with neurocognitive and genomic correlatives.

ClinicalTrials.gov ID: NCT04222062

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/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 1–4 resectable brain metastases (≥1 lesion 20–50 mm) from solid tumors (excluding SCLC, lymphoma, germ cell), KPS ≥70, receive neoadjuvant stereotactic radiosurgery to the target lesion followed by gross total resection within 2 weeks; remaining lesions, if any, are treated with SRS. Excludes prior WBRT, brainstem lesions, leptomeningeal disease, and inability to meet optic apparatus dose constraints.

ClinicalTrials.gov ID: NCT01891318

A Phase I/II Study of Ex-Vivo Expanded Allogeneic Universal Donor (UD) TGFbi NK Cell Infusions in Combination With Temozolomide as a Lymphodepleting Agent in Patients With Melanoma Metastatic to the Brain

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 progressive melanoma brain metastases (measurable ≥10 mm, ECOG 0–2) receive temozolomide lymphodepletion followed by IV infusions of ex vivo–expanded allogeneic TGF-β–inhibited NK cells, which are designed to resist TGF-β–mediated immunosuppression and enhance NK cytotoxicity in the CNS. Key exclusions include leptomeningeal disease and need for immediate stereotactic radiotherapy; corticosteroids allowed if stable/minimal.

ClinicalTrials.gov ID: NCT05588453

Phase I/II Study of Lutathera in Patients With Recurrent and/or Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET

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: Enrolling children to young adults (ages 4–39) with recurrent/progressive high-grade primary CNS tumors or meningiomas that are SSTR-positive on DOTATATE PET (Krenning ≥2). Participants receive 177Lu-DOTATATE (Lutathera), a somatostatin receptor 2–targeted peptide receptor radionuclide therapy delivering beta-emitting 177Lu, IV every 8 weeks for up to 4 cycles.

ClinicalTrials.gov ID: NCT05278208

A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Stereotactic Radiation Therapy 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.

No known activity

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

HealthScout AI summary: Adults with solid-tumor brain metastases (largest lesion ≤2 cm), off steroids before SRS and ≥2 months from prior cranial RT, receive stereotactic radiosurgery plus azeliragon, an oral RAGE inhibitor aimed at reducing inflammation/vascular dysfunction and potentially overcoming radioresistance. Single-arm dose-finding then expansion assesses safety and early intracranial response versus historical SRS outcomes; excludes leptomeningeal disease and strong CYP2C8 inhibitor use.

ClinicalTrials.gov ID: NCT05789589

Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors

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 a single resectable intraparenchymal brain metastasis (solid tumors; ECOG 0–2; ≤10 total brain lesions) are randomized to stereotactic radiosurgery given either before or after surgical resection, excluding prior WBRT, leptomeningeal disease, lesions near the optic chiasm, very large lesions (>5 cm), or certain histologies. The trial compares pre-op versus post-op SRS using standard-of-care techniques to determine impact on CNS control (local recurrence, LMD, symptomatic radiation necrosis) and survival/quality-of-life outcomes.

ClinicalTrials.gov ID: NCT03750227

A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma 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 BRAF V600–mutant melanoma and active, measurable brain metastases (including leptomeningeal disease), no prior systemic therapy for metastatic disease, are randomized to encorafenib (BRAF inhibitor) + binimetinib (MEK1/2 inhibitor) plus nivolumab (PD-1 antibody) versus standard ipilimumab (CTLA-4 antibody) + nivolumab. Allows limited steroids, extracranial disease, and prior adjuvant/neoadjuvant therapy; excludes uveal melanoma and significant autoimmune or recent radiation contraindications.

ClinicalTrials.gov ID: NCT04511013

A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS 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 1+ surgically resectable brain metastases (≤4 cm single-fraction or ≤7 cm multifraction; KPS ≥70/ECOG ≤2; no prior brain RT or LMD; excluding SCLC, lymphoma, leukemia, myeloma) are randomized to pre-operative SRS followed by craniotomy versus surgery followed by adjuvant SRS. The trial compares these standard-of-care strategies for 1-year leptomeningeal disease, with secondary endpoints including local/distant brain control, survival, neurocognition, and quality of life.

ClinicalTrials.gov ID: NCT03741673