Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma

Exclusion Criteria

• •Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
• •* Pregnant persons
• •* Nursing persons
• •* Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
• •Recurrence ≤ 4 weeks after the completion of RT, defined from the imaging assessment immediately after completion of RT
• •Three or more prior systemic treatments for recurrent or progressing disease
• •Diagnosis of porphyria, or hypersensitivity to porphyrins
• •Failure to recover to grade 1 or baseline from any adverse events (AEs) (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) related to prior anticancer therapy
• •* EXCEPTIONS: Alopecia, lymphopenia, peripheral neuropathy, and ototoxicity ≤ grade 3)
• •Known history of the following conditions:
• •* Allergy to gadolinium contrast agents
• •* Patients known to be HIV positive and currently receiving antiretroviral therapy
• •* NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
• •Inability to undergo MRI scans
• •Uncontrolled intercurrent illness including, but not limited to:
• •* Ongoing or active infection
• •* Patients with platelet count \< 100
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Or psychiatric illness/social situations that would limit compliance with study requirements
• •History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens