Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma

  • STATUS
    Recruiting
  • days left to enroll
    68
  • participants needed
    30
  • sponsor
    Nader Sanai
Updated on 29 March 2021

Summary

A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 30 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).

Details
Condition High Grade Glioma, malignant glioma
Treatment SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
Clinical Study IdentifierNCT04559685
SponsorNader Sanai
Last Modified on29 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard (Stupp regimen) therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy
Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI with positive perfusion
Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with a volume of at least 6 cm3 and 20cm3 of targeted treatment area
Age 18 at time of consent
Have a performance status (PS) of 2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982)
Ability to swallow oral medications
Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility)
Adequate bone marrow function
absolute neutrophil count 1,000/mcL
Platelets (at time of surgery) 100,000/mcL
hemoglobin 8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator
Adequate hepatic and renal function
total bilirubin 1.5 X ULN. Participants with Gilbert's syndrome with a total bilirubin 2.0 times ULN and direct bilirubin within normal limits are permitted
AST(SGOT) 3 X institutional ULN
ALT(SGPT) 3 X institutional ULN
GGT 3 X institutional ULN
Serum creatinine 1.5 X institutional ULN 8. Confirmed negative serum pregnancy test (-hCG) before starting study treatment or participant has had a hysterectomy. 9. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of treatment administration. 10. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 1 month after the end of treatment administration. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid. 11. Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade 1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 21 days is required between last chemotherapy dose and Day 1 (provided the patient did not receive radiotherapy). 12. Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and Day 1. 13. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable). 14. Has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. 15. Willingness and ability to comply with scheduled visits, treatment plans, Lifestyle Considerations, laboratory tests and other procedures

Exclusion Criteria

Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment
Have had a recent (3 months prior to first dose of study drug) transient ischemic attack or stroke
Significant vascular disease (e.g. aortic aneurysm)
Evidence of bleeding diathesis or coagulopathy
Diagnosis of porphyria
Unstable angina and/or congestive heart failure within the last 6 months
Transmural myocardial infarction within the last 6 months
Serious and inadequately controlled cardiac arrhythmia
Acute exacerbation of chronic obstructive pulmonary disease
Inability to undergo MRI (e.g., presence of a pacemaker)
Pregnancy or breastfeeding
Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
Hypersensitivity against porphyrins
Treatment with another investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
Has an Overall Skull Density Ratio of 0.45 (0.05) or less as calculated from the screening CT
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