RECRUITING

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

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Conditions

Progressive GlioblastomaRecurrent Glioblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase Ib trial tests the safety, best dose, and effectiveness of SONALA-001 in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001, to kill tumor cells. SONALA-001 binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 with MRgFUS may be safe, tolerable, and/or effective in treating patients with progressive or recurrent glioblastoma.

Official Title

Phase 1B Dose Escalation And Expansion Study of Sonodynamic Therapy With SONALA-001 in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound (MRgFUS) in Patients With Progressive or Recurrent Glioblastoma Multiforme (rGBM)

Quick Facts

Study Start:2025-08-14
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07076472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * 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
  3. * Radiographic evidence of disease which may be measurable or non-measurable
  4. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  5. * Previous treatment with radiotherapy (RT)
  6. * Have a life expectancy of ≥ 12 weeks
  7. * Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
  8. * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
  9. * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
  10. * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)
  11. * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
  12. * Albumin ≥ 3 g/dL (obtained ≤ 15 days prior to registration)
  13. * Potassium ≥ lower limit of normal (LLN) (obtained ≤ 15 days prior to registration)
  14. * Serum total calcium ≥ LLN (obtained ≤ 15 days prior to registration)
  15. * Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
  16. * Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
  17. * Provide written informed consent
  18. * 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
  19. * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  1. * 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:
  2. * Pregnant persons
  3. * Nursing persons
  4. * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
  5. * Recurrence ≤ 4 weeks after the completion of RT, defined from the imaging assessment immediately after completion of RT
  6. * Three or more prior systemic treatments for recurrent or progressing disease
  7. * Diagnosis of porphyria, or hypersensitivity to porphyrins
  8. * 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
  9. * EXCEPTIONS: Alopecia, lymphopenia, peripheral neuropathy, and ototoxicity ≤ grade 3)
  10. * Known history of the following conditions:
  11. * Allergy to gadolinium contrast agents
  12. * Patients known to be HIV positive and currently receiving antiretroviral therapy
  13. * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  14. * Inability to undergo MRI scans
  15. * Uncontrolled intercurrent illness including, but not limited to:
  16. * Ongoing or active infection
  17. * Patients with platelet count \< 100
  18. * Symptomatic congestive heart failure
  19. * Unstable angina pectoris
  20. * Cardiac arrhythmia
  21. * Or psychiatric illness/social situations that would limit compliance with study requirements
  22. * History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  23. * 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

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Terence C. Burns, MD, PhD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Terence C. Burns, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-14
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-08-14
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Progressive Glioblastoma
  • Recurrent Glioblastoma