Clinical Trials for Brain Tumor

A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma

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 recurrent, resectable WHO grade 3–4 frontal lobe glioma that is mTOR‑pathway positive (e.g., PTEN loss or PI3K/AKT/mTOR alterations) after prior Stupp regimen receive a single pre-resection dose of temsirolimus given via super-selective intra-arterial infusion or standard IV. Temsirolimus is an mTORC1 inhibitor; the study compares intratumoral drug exposure and target inhibition (pS6) between delivery routes.

ClinicalTrials.gov ID: NCT05773326

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

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 advanced cancers and actively progressing, measurable, untreated asymptomatic brain metastases (including BRCA1/2-mutated, other HRR-aberrant tumors, SCLC, NSCLC, and TNBC) receive niraparib (PARP inhibitor exploiting HRD/synthetic lethality) plus dostarlimab (PD‑1 inhibitor) to assess intracranial response and durability; prior PD‑1/L1 allowed, prior full‑dose PARP monotherapy excluded. Requires ECOG 0–2, adequate organ function, no leptomeningeal disease, and no need for immediate local therapy or steroids.

ClinicalTrials.gov ID: NCT05700721

Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar 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: Children and young adults (3 to <22 years) with recurrent or progressive malignant cerebellar brain tumors (e.g., medulloblastoma, high‑grade glioma/GBM, ependymoma, ATRT, PNET, germ cell tumor) with surgically accessible lesions ≤3 cm receive intratumoral G207, an engineered, tumor‑selective oncolytic HSV‑1 (γ34.5 deletions, UL39 inactivation; TK‑retained), with later cohorts also receiving a single 5‑Gy focal radiation dose within 24 hours. Key exclusions include diffuse multifocal disease (≥3 lobes), need for ventricular/brainstem inoculation or access, active infection/immunosuppression, and concurrent anticancer therapy.

ClinicalTrials.gov ID: NCT03911388

DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements

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 treatment-naïve, stage IV ALK-rearranged NSCLC and asymptomatic or minimally symptomatic brain metastases are randomized to alectinib (ALK TKI with strong CNS activity) alone with delayed brain RT versus upfront stereotactic radiosurgery followed by alectinib. Designed to assess neurologic outcomes and CNS control, with a Phase 1b run-in for safety/feasibility of alectinib.

ClinicalTrials.gov ID: NCT05987644

A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion

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 recurrent/progressive IDH–wild type glioma (WHO grade 2–4) harboring a CLIA-confirmed FGFR–TACC fusion receive oral erdafitinib monotherapy (continuous 28-day cycles) until progression/toxicity. Erdafitinib is a pan-FGFR1–4 tyrosine kinase inhibitor targeting the oncogenic FGFR–TACC fusion; prior FGFR inhibitor exposure is excluded.

ClinicalTrials.gov ID: NCT05859334

The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins

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 (ECOG 0–2) with histologically confirmed non-hematologic malignancy and 1–5 intact, well-circumscribed intraparenchymal brain metastases on MRI (each ≤3.0 cm; excluding brainstem/near optic apparatus, leptomeningeal disease, or recent cranial RT/SRS) are randomized to frameless LINAC-based stereotactic radiosurgery planned with either a 0 mm versus 2 mm GTV-to-PTV margin. The study tests whether omitting the PTV margin maintains intracranial control while reducing radiation-related imaging changes/toxicity (e.g., radionecrosis/pseudoprogression).

ClinicalTrials.gov ID: NCT02747303

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types

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: Enrolling adults (ECOG 0–2) with newly diagnosed extensive-stage small cell lung cancer on standard platinum/etoposide plus PD-L1 inhibitor chemoimmunotherapy (≤3 cycles at enrollment, no prior thoracic RT) to receive response-adaptive ultrahypofractionated thoracic stereotactic RT (PULSAR) in up to three 7–10 Gy “pulses” timed around infusion days, with pulses omitted if complete response occurs. Also enrolling adults with 1–5 MRI-defined brain metastases (2–5 cm; brainstem 1.5–5 cm; no prior WBRT or prior focal therapy to target lesions) for two-pulse fractionated SRS/FSRT where a 4-week response MRI can de-escalate treatment by omitting pulse 2 if ≥25% volume reduction.

ClinicalTrials.gov ID: NCT07139990

Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)

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 radiographically confirmed intact brain metastasis 2–5 cm (KPS ≥60), neurologically stable, MRI-eligible, and lesions ≥5 mm from the optic apparatus; up to two large lesions may be treated (with up to 10 additional <2 cm metastases allowed for concurrent single-fraction SRS). Patients are randomized to staged SRS 24–30 Gy in 2 fractions with the second fraction ~30 days later versus FSRT 27 Gy in 3 daily fractions over 3–5 days (with concurrent single-fraction SRS for smaller lesions as needed).

ClinicalTrials.gov ID: NCT07227610

A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction

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 (≥18) with solid tumors and at least one intact/residual/recurrent “volatile” brain metastasis at higher risk for interval change/displacement (e.g., rapid growth, near edema or recent surgical cavity), KPS ≥60 and expected survival ≥3–6 months, are treated with same-day MRI-simulated, adaptively planned LINAC-based stereotactic radiosurgery/radiotherapy. Patients are randomized to stereotactic radiation using a 0 mm versus 1 mm planning target volume margin to test whether tighter margins can maintain control while reducing geographic miss and toxicity (e.g., radiation necrosis).

ClinicalTrials.gov ID: NCT07132190

Initial Safety Lead-in Followed by a Phase II Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (The Breast CMV 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: Adults with metastatic breast cancer, progressive brain metastases, and CMV viremia or seropositivity receive oral valganciclovir added to standard-of-care systemic and/or local CNS therapy, with at least one untreated progressive brain lesion followed for response. Valganciclovir is a ganciclovir prodrug that inhibits viral DNA polymerase to suppress CMV replication; its antitumor role in CMV-associated breast cancer brain metastases is investigational.

ClinicalTrials.gov ID: NCT07383649