Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma (NCT05362409) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma
United States22 participantsStarted 2022-06-29
Plain-language summary
A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements
✓. ≥ 18 years of age
✓. WHO performance status of ≤ 2 at screening
✓. Part A: Previous histopathologically confirmed diagnosis of high-grade glioma and radiographic evidence of recurrence after prior therapy with radiotherapy. Eligible histologies include (according to WHO classification 2021):
✓. Astrocytoma, WHO grade 3 and 4 (including subtypes)
✓. Oligodendroglioma WHO grade 3 (including subtypes)
✓. Unifocal or multifocal tumor confined to the supratentorial compartment
✓. Interval since last anti-cancer therapy relative to first 5-ALA treatment, as detailed below
Exclusion criteria
✕. Primary infratentorial or brainstem tumors
✕. Primary spinal cord tumors
✕. Bihemispheric disease (enhancing or non-enhancing) or tumors that involve the bilateral corpus callosum
✕. Women who are pregnant or breastfeeding
✕. Inability to undergo MRI or receive gadolinium (Gd)-based contrast agents
What they're measuring
1
Incidence of adverse events (Safety and Tolerability)
Timeframe: 12 Months
2
To determine the Maximum Tolerable Duration (MTDu)
✕. Average skull thickness at the treatment field \> 10 mm as assessed by Alpheus Medical.
✕. Hemorrhagic or ischemic stroke (including transient ischemic attacks) and central nervous system bleeding in the preceding 6 months that are not related to glioma surgery. History of prior intratumoral bleeding is not an exclusion criterion; however, patients with a history of prior intratumoral or intracranial bleeding will undergo a non-contrast head CT to exclude acute bleeding.