A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)

Overview

About this study

The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥18 years

  • Pathological confirmation of recurrent glioblastoma (as defined in 2021 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

  • ECOG Performance Status (PS) 0, 1 or 2

  • Previous treatment with radiotherapy (RT)

  • Have a life expectancy of ≥12 weeks.

  • The following laboratory values obtained ≤15 days prior to registration:

    • Hemoglobin ≥9.0 g/dL

    • Absolute neutrophil count (ANC) ≥1500/mm3

    • Platelet count ≥100,000/mm3

    • Total bilirubin ≤1.5 x ULN

    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN (≤5 x ULN for patients with liver involvement)

    • Albumin ≥3 g/dL

    • Potassium ≥LLN

    • Serum total calcium ≥LLN

    • Creatinine ≤1.5 x ULN OR Calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault formula

  • Negative pregnancy test done ≤8 days prior to registration, for persons of childbearing potential only

  • Negative pregnancy test done ≤8 days prior to registration, for persons of childbearing potential only

  • Willing to participate in the Neuro-oncology biorepository (IRB 12-003458, 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 AEs (CTCAE 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 05/08/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Terence Burns, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20586926

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