The Stanford Neuro-Oncology Program Adult Clinical Trials

Newly Diagnosed Glioma 

A Phase II Study of BPM31510 with Vitamin K1 in Subjects with Newly Diagnosed Glioblastoma (GB)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04752813

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune (TTFields, 200 kHz) concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma
PI: Lawrence Recht, MD
ClinicalTrials.gov#: NCT06556563

Recurrent High Grade Glioma 

Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults with Recurrent Glioblastoma Multiforme (GBM)
PI: Reena Thomas, MD PhD
ClinicalTrials.gov#: NCT05474378

A Randomized Surgical Window of Opportunity Study with Dose Escalation to Evaluate Whether Oral Fluoxetine Can Induce Cytotoxic Lysosomal Stress and Enhance Temozolomide Efficacy in Clinical Glioma (The FLIrT Trial)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT05634707

A Phase I Study of Multiple Doses of Neural Stem Cell-Based Oncolytic Virotherapy (NSC-CRAd-S-pk7) Administered Intracerebrally to Patients with Recurrent High Grade Gliomas
PI: Melanie Hayden Gephart, MD
ClinicalTrials.gov#: NCT05139056

A Phase 2, multicenter, clinical study to evaluate the efficacy and safety of safusidenib erbumine in patients with isocitrate dehydrogenase 1 (IDH1)-mutant glioma
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT05303519

H3K27M Mutant Glioma

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
*Stanford is only enrolling adult participants*
PI: Kate Therkelsen, MD
ClinicalTrials.gov#: NCT05580562

Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T Cells (GD2CART) for Diffuse Intrinsic Pontine Gliomas (DIPG) and Spinal Diffuse Midline Glioma (DMG)
PI: Michelle Monje, MD PhD
ClinicalTrials.gov #: NCT04196413

Brain and Spine Metastases 

A Phase IIa Study Assessing QBS72S For Treating Brain Metastases
PI: Melanie Hayden Gephart, MD
ClinicalTrials.gov#: NCT05305365

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
PI: Scott Soltys, MD
ClinicalTrials.gov#: NCT05438212

A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients with Spinal Metastases (ALL-STAR)
PI: Erqi Pollum, MD
ClinicalTrials.gov#: NCT06173401

Phase III Trial of Single Fraction Stereotactic Radiosurgery vs Fractionated Radiosurgery for Intact Brain Metastases
PI: Scott Soltys, MD
ClinicalTrials.gov#: NCT06500455