Clinical Trials for Brain Tumor

Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

TrialFetch AI summary: Adults with recurrent WHO grade IV glioblastoma planned for repeat resection and re-irradiation receive neoadjuvant pembrolizumab (anti–PD-1 monoclonal antibody) combined with stereotactic radiation therapy, followed by surgery. Key exclusions include prior checkpoint inhibitor therapy, contraindication to re-irradiation, significant immunosuppression, or pembrolizumab hypersensitivity.

ClinicalTrials.gov ID: NCT04977375

Chronic Convection Enhanced Delivery of Topotecan for Recurrent Malignant Glioma

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

PEACH TRIAL- Precision mEdicine and Adoptive Cellular tHerapy for the Treatment of Recurrent Neuroblastoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)

TrialFetch AI summary: Children and young adults with newly diagnosed DIPG/brainstem glioma (pre‑radiation, biopsy‑amenable) or relapsed/refractory high‑risk neuroblastoma receive autologous tumor‑reactive T cells (TTRNA‑xALT), generated by priming patient T cells with total tumor RNA–loaded dendritic cells to create a broad, personalized antitumor T‑cell repertoire. Dose‑escalated infusions (3×10^6–3×10^8 cells/kg) assess safety/MTD, with manufacturing feasibility and clinical activity as secondary endpoints.

ClinicalTrials.gov ID: NCT04837547

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

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

Phase I Clinical Trial of GPC2 Chimeric Antigen Receptor T (GPC2-CAR T) Cells for Relapsed or Refractory Medulloblastoma in Children and Young Adults

TrialFetch AI summary: Children and young adults (12 months–30 years) with GPC2-positive relapsed/refractory medulloblastoma or other eligible CNS embryonal tumors receive autologous GPC2-directed CAR T cells via intracerebroventricular infusions after fludarabine/cyclophosphamide lymphodepletion. GPC2-CAR T targets glypican-2 (oncofetal heparan sulfate proteoglycan) with locoregional delivery and intrapatient dose escalation over up to 8 cycles.

ClinicalTrials.gov ID: NCT07087002

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)

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

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

A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression

TrialFetch AI summary: Enrolls adults with locally advanced/metastatic/unresectable solid tumors harboring ERBB2 (HER2) activating alterations, NRG1 fusions, or HER2 overexpression, with expansion cohorts for ERBB2-mutant NSCLC with brain metastases and ERBB2-mutant or HER2-overexpressing breast cancer with brain metastases ± leptomeningeal disease. Patients receive oral CGT4255, an investigational EGFR-sparing selective HER2 tyrosine kinase inhibitor designed to cover multiple oncogenic HER2 mutations with CNS penetration, given at escalating/selected doses.

ClinicalTrials.gov ID: NCT07361562