Clinical Trials for Brain Tumor

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer 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.

TrialFetch AI summary: This trial enrolls adults with HER2-negative metastatic breast cancer and measurable brain metastases (ECOG 0-1, ≤3 prior chemo regimens) to receive utidelone, a microtubule-stabilizing epothilone analog, alone or with capecitabine. Key exclusions include prior capecitabine failure, leptomeningeal disease, or lesions needing urgent intervention.

ClinicalTrials.gov ID: NCT06764940

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot 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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329

Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer

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: This trial enrolls adults with biopsy-proven estrogen receptor (ER)-positive breast cancer and new or recurrent brain metastases who are candidates for planned radiation therapy, using investigational brain imaging with 18F-FES PET/CT (a radiotracer targeting ER expression) in addition to standard imaging to potentially enhance radiotherapy planning and response assessment.

ClinicalTrials.gov ID: NCT06072807

Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer

Active drug

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

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.

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: Relapsed/refractory primary CNS tumors in patients aged 6–25 (e.g., ependymoma, medulloblastoma, glioblastoma) with measurable disease and adequate organ function; key exclusions include active autoimmune disease requiring systemic therapy, significant cardiovascular/bleeding risks, warfarin/strong CYP3A inhibitors, and uncontrolled infection. Single-arm regimen of oral ibrutinib (BTK inhibitor) plus indoximod (IDO/TDO pathway modulator restoring T-cell function) with metronomic cyclophosphamide and etoposide in 28+ day cycles.

ClinicalTrials.gov ID: NCT05106296

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

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.

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 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

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

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

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.

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: 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