Clinical Trials for Brain Tumor

Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 or progressive high-grade astrocytoma (glioblastoma or anaplastic astrocytoma) undergoing surgical debulking receive a single intraoperative intratumoral injection of a replication-competent adenovirus (Ad5-yCD/mutTKSR39rep-ADP) carrying yeast cytosine deaminase and mutant HSV1-thymidine kinase plus adenovirus death protein, followed by fractionated stereotactic radiosurgery. Postoperatively, patients take 5-fluorocytosine and valganciclovir to activate intratumoral prodrug-to-toxin conversion and enhance oncolysis/radiosensitization; key exclusions include immunosuppression, active infections, viral hepatitis/HIV, and prior intratumoral gene/viral therapies.

ClinicalTrials.gov ID: NCT05686798

Pilot Study of Sonodynamic Therapy With 5-ALA for the Treatment of Recurrent Glioblastoma Using Neuronavigation-Guided Low-Intensity Focused Ultrasound

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.

TrialFetch AI summary: Adults (KPS 70–100) with measurable, surgically accessible recurrent glioblastoma scheduled for repeat craniotomy receive a single session of sonodynamic therapy using oral 5-ALA (prodrug metabolized to PpIX that accumulates in glioma cells) activated by neuronavigation-guided low-intensity focused ultrasound to a portion of the enhancing lesion 1–3 weeks before resection. Designed to assess safety/feasibility and preliminarily evaluate tumor devitalization, with key exclusions including porphyria/5-ALA hypersensitivity, recent chemo/radiation, anticoagulation that can’t be held, significant cardiopulmonary disease, or anatomy outside the NaviFUS treatment envelope.

ClinicalTrials.gov ID: NCT06039709

Targeting Macrophage Migration Inhibitory Factor: A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas

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.

TrialFetch AI summary: Adults with progressive WHO grade 4 gliomas undergoing planned resection and eligible for postoperative chemotherapy receive sitagliptin (DPP-4 inhibitor targeting MDSC trafficking/function) given preoperatively in most patients and then continued with standard chemotherapy postoperatively. Aims to increase intratumoral CD8+ T-cell infiltration and assess PFS/OS and safety; excludes patients with prior gliptin use or uncontrolled diabetes requiring insulin/sulfonylureas.

ClinicalTrials.gov ID: NCT07003542

Adopting a Functional Precision Medicine Approach For Individualized Pediatric Cancer Treatments

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.

TrialFetch AI summary: Children, adolescents, and young adults (≤21 years) with relapsed or refractory solid or hematologic malignancies and accessible tumor tissue undergo ex vivo drug sensitivity testing integrated with genomic profiling to guide individualized therapy selection. Treating physicians may use matched, typically approved monotherapies or combinations based on predicted sensitivity; outcomes are compared with contemporaneous patients receiving non–FPM standard-of-care therapy.

ClinicalTrials.gov ID: NCT05857969

UAB 2507 - Randomized Phase II Study of Differential Margins in Single Isocenter Radiosurgery of 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.

TrialFetch AI summary: Adults with up to ~20 brain metastases (each ≤4 cm), including intact lesions or postoperative cavities and even after prior WBRT, are randomized to linac-based single-isocenter SRS using either 0 mm or 2 mm PTV margins. The trial compares local control and grade ≥3 CNS toxicity at 12 months with standard SRS dosing (16–20 Gy ×1 for <2 cm; 27 Gy in 3 fractions for 2–4 cm); no investigational drugs are used.

ClinicalTrials.gov ID: NCT06857006

Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)

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.

TrialFetch AI summary: Children and young adults (6–21) with recurrent primary brain tumors lacking curative options or relapsed/refractory solid tumors after ≥2 prior lines receive standard chemotherapy plus dapagliflozin, an SGLT2 inhibitor (metabolic modulation via reduced glucose/insulin and ketone shift) to assess safety/feasibility and preliminary activity. Regimens include carmustine+dapagliflozin for brain tumors and topotecan/cyclophosphamide+dapagliflozin for solid tumors, with age-based dapagliflozin dosing and close metabolic/renal monitoring due to risks such as euglycemic ketoacidosis and infections.

ClinicalTrials.gov ID: NCT05521984

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)

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.

TrialFetch AI summary: Adults with HER2-positive metastatic solid tumors (including ERBB2-mutant) and active/progressing brain metastases not needing immediate local CNS therapy receive tucatinib (selective HER2 TKI with CNS penetration) plus ado-trastuzumab emtansine (HER2-directed antibody–drug conjugate) in 21-day cycles after prior HER2 therapy as applicable. Aims to assess intracranial response and safety; excludes patients with large/unstable brain lesions or needing urgent local therapy.

ClinicalTrials.gov ID: NCT05673928

EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active Systemic Therapy Options

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.

TrialFetch AI summary: Adults with metastatic solid tumors and low-risk, untreated brain metastases (ECOG 0–1) start CNS-active standard systemic therapy; responders with non-complete response are randomized to consolidative stereotactic radiosurgery (SRS) to all residual lesions versus observation, while those with CNS progression are randomized to SRS to progressing lesions alone versus SRS to progressing lesions plus consolidative SRS to all residual lesions. Excludes leptomeningeal disease, SCLC, hematologic malignancies, large (>3 cm) or hemorrhagic lesions, prior WBRT, and certain oncogene-driven NSCLC starting highly CNS-active targeted therapy.

ClinicalTrials.gov ID: NCT06649058

Phase I Study of Cellular Immunotherapy Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Children With Recurrent/Refractory Malignant Brain Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 patients with recurrent or refractory IL13Rα2-positive malignant brain tumors receive lymphodepleting cyclophosphamide/fludarabine followed by repeated intraventricular infusions of autologous IL13Rα2-targeted CAR T cells (IL-13 mutein binder, 4-1BB/CD3ζ; includes truncated CD19). Locoregional delivery aims to enhance CNS exposure while monitoring safety, CAR T persistence, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT04510051

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma 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.

TrialFetch AI summary: Adults with melanoma and at least one measurable, untreated brain metastasis (0.5–3 cm), ECOG 0–1, and no steroid-requiring neurologic symptoms receive fixed-dose nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 inhibitor) IV every 28 days. Prior limited SRT/excision allowed if non-irradiated measurable disease remains; excludes leptomeningeal disease, lesions >3 cm, prior metastatic PD-1 therapy, and significant autoimmune/infectious comorbidities.

ClinicalTrials.gov ID: NCT05704647