Clinical Trials for Brain Tumor

Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases

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 brain metastases from any solid tumor scheduled for standard-fractionation WBRT are randomized to receive L-arginine either intravenously or orally prior to each fraction, without concurrent systemic therapy. L-arginine, a nitric oxide synthase substrate that may enhance radiosensitivity via improved tumor oxygenation and immune modulation, is being evaluated for pharmacokinetics, safety, and physiologic effects to inform dosing and route.

ClinicalTrials.gov ID: NCT06328686

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)

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 resectable brain tumors, including HER2-expressing or ERBB2-mutant brain metastases (HER2-high, HER2-low, or HER2-mutant) and HER2-expressing recurrent glioblastoma; includes patients with or without prior T-DXd. Patients receive perioperative trastuzumab deruxtecan (HER2-directed antibody-drug conjugate delivering a topoisomerase I inhibitor) to assess intratumoral penetration and preliminary efficacy.

ClinicalTrials.gov ID: NCT06058988

A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma 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 metastatic RCC and at least one measurable untreated or locally progressive brain metastasis (asymptomatic/mildly symptomatic, largely steroid-independent; ECOG 0–2) receive nivolumab (PD‑1 inhibitor) plus ipilimumab (CTLA‑4 inhibitor) with cabozantinib (MET/VEGFR/AXL TKI), with maintenance nivolumab/cabozantinib; prior systemic therapy allowed if no prior CTLA‑4, cabozantinib, or MET inhibitor. Primary aim is to improve intracranial PFS; a safety lead-in may omit ipilimumab if excess toxicity.

ClinicalTrials.gov ID: NCT05048212

Chronic Convection Enhanced Delivery of Topotecan for Recurrent Malignant 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.

TrialFetch AI summary: Adults with recurrent IDH1/2-mutant malignant glioma (WHO grade 3–4), KPS ≥70, with a stereotactically accessible enhancing lesion <32 cc after failing standard therapy receive intratumoral topotecan via chronic, pulsatile convection-enhanced delivery through an implanted pump and catheter. Topotecan is a topoisomerase I inhibitor; co-infused gadolinium enables imaging of distribution, with four 48-hour infusions over ~1 month and safety/response assessed by CTCAE and RANO.

ClinicalTrials.gov ID: NCT06666712

GPC-3 Chimeric Antigen Receptor T Cells FOR Recurrent GPC-3 Positive Glioblastoma

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 (≥18) with recurrent glioblastoma undergoing clinically indicated repeat resection whose tumor is GPC3-positive by IHC (≥25% with at least moderate intensity) and KPS ≥60. At surgery, patients receive a single intracavitary dose of autologous GPC3-targeted CAR T cells (GC33-derived) engineered to express IL-15 for enhanced expansion/persistence and incorporating an inducible caspase-9 (iCasp9) safety switch activatable with AP1903 if needed for toxicity control.

ClinicalTrials.gov ID: NCT06815432

A Prospective, Open-Label, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of 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, histologically confirmed glioblastoma after radiotherapy and temozolomide, without multifocal enhancing disease or prior anti-VEGF therapy, receive bevacizumab 10 mg/kg IV every 2 weeks. After each infusion, NaviFUS focused ultrasound with Lumason microbubbles is used to transiently open the blood-brain barrier in the tumor region to potentially enhance local delivery of bevacizumab, an anti-VEGF monoclonal antibody.

ClinicalTrials.gov ID: NCT06329570

PNOC042: A Phase 2, Multi-institutional Trial, Evaluating the Efficacy of Laser Interstitial Thermal Therapy (LITT) in Children, Adolescents and Young Adults With Recurrent or Progressive Low-grade Gliomas (LGG)

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 patients ages 2–25 with recurrent or progressive pediatric low-grade glioma after at least one prior therapy, with CNS lesions centrally deemed safe and suitable for stereotactic MRI-guided laser interstitial thermal therapy. All participants receive LITT thermal ablation, with optional adjunctive cyst aspiration, followed by MRI surveillance for disease control.

ClinicalTrials.gov ID: NCT07506239

Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)

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 solid tumor brain metastases showing progression ≥3 months after prior stereotactic radiosurgery are enrolled if they have measurable intracranial disease, KPS ≥60, MRI eligibility, and no leptomeningeal disease. Patients eligible for surgery or LITT undergo local treatment and are randomized to close MRI surveillance versus adjuvant repeat stereotactic radiosurgery; those ineligible for surgery/LITT receive repeat SRS alone in a descriptive cohort.

ClinicalTrials.gov ID: NCT07053033

A Phase 1 Study of a Combined Cytotoxic and Immune-Stimulatory Therapy in Pediatric and Young Adult Patients With Recurrent, Primary Malignant 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: Enrolls children, adolescents, and young adults (3–25 years; up to 39 for recurrent diffuse hemispheric glioma, H3 G34-mutant) with surgically resectable recurrent/progressive malignant primary brain tumors after standard therapy. Treatment is intratumoral/peritumoral AdV-HSV1-TK plus AdV-Flt3L at resection followed by oral valacyclovir; HSV-TK/valacyclovir is a suicide gene cytotoxic strategy, and Flt3L is intended to recruit/activate dendritic cells to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT06914479

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

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, adolescents, and young adults (12 months–21 years) with newly diagnosed high-grade glioma, including DIPG/diffuse midline glioma, harboring an ALK or ROS1 fusion receive oral lorlatinib, a brain-penetrant third-generation ALK/ROS1 tyrosine kinase inhibitor, for 2 cycles upfront. Subsequent therapy is response- and age-adapted, with continuation of lorlatinib alone for complete responders, lorlatinib plus pediatric chemotherapy for selected younger patients, or lorlatinib maintenance after focal radiotherapy for older patients.

ClinicalTrials.gov ID: NCT06333899