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Search / Trial NCT07076472

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

Launched by MAYO CLINIC · Jul 15, 2025

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called sonodynamic therapy for people with glioblastoma, a type of brain tumor that has either come back after treatment or is getting worse. The treatment combines a special drug called SONALA-001 with a focused ultrasound technique guided by MRI imaging. This method uses sound waves to activate the drug right at the tumor site, aiming to kill cancer cells without harming healthy brain tissue. The main goals of the study are to find out if this treatment is safe, what dose works best, and whether it helps control the tumor.

Adults who have confirmed recurrent or progressive glioblastoma and have already received radiation treatment may be eligible to join. Participants should be in generally good health with certain blood counts and organ functions within specific ranges. The trial is not yet recruiting, but those who take part will undergo non-invasive ultrasound sessions along with the drug treatment and will be closely monitored to track safety and any effects on their tumor. It’s important to note that pregnant or nursing individuals, people with certain other health issues, or those unable to have MRI scans won’t be eligible. This study offers a new approach that may provide hope for patients with challenging brain tumors, using a treatment that targets cancer cells precisely while aiming to minimize side effects.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years
  • Pathological confirmation of recurrent glioblastoma (as defined in 2021 World Health Organization \[WHO\] Classification of Tumors of the Central Nervous System; Louis, Perry, et al. 2021) that has recurred or progressed, and for which resection is not indicated as assessed by the study physician
  • Radiographic evidence of disease which may be measurable or non-measurable
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Previous treatment with radiotherapy (RT)
  • Have a life expectancy of ≥ 12 weeks
  • Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
  • Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
  • Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
  • Albumin ≥ 3 g/dL (obtained ≤ 15 days prior to registration)
  • Potassium ≥ lower limit of normal (LLN) (obtained ≤ 15 days prior to registration)
  • Serum total calcium ≥ LLN (obtained ≤ 15 days prior to registration)
  • Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
  • Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
  • Provide written informed consent
  • Willing to participate in the neuro-oncology biorepository \[Institutional Review Board (IRB) 12-003458, principal investigator (PI): Jann Sarkaria, MD, PhD\] for collecting and archiving biospecimens samples on neuro-oncology patients
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • 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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Terence C. Burns, MD, PhD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported