SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) for Brain Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brain TumorSONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment that uses sound waves and a light-sensitizing drug. Researchers want to see if it is safe and if it works on brain cancer.

Eligible Conditions
  • Brain Tumor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 24 months

24 months
Best Overall Response (BOR)
Overall Survival
6 months
Progression-free survival
Day 1
Performance of MRgFUS
Day 6
To identify oxidative stress in tissue exposed to sonodynamic therapy in recurrent high-grade glioma patients.
Day 14
Biological changes associated with the sonodynamic therapy
Radiographic evidence of tumor physiological imaging changes associated with SDT in recurrent HGG patients (Arm E)
To characterize the biological changes associated with sonodynamic therapy in recurrent high-grade glioma patients.
Day 14
Radiographic evidence of tumor physiological imaging changes associated with sonodynamic therapy
Day 30
Safety and Tolerability

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Arm B Time-escalation
1 of 6
Arm C ALA Dose-escalation
1 of 6
Arm A Energy Dose-escalation
1 of 6
Arm D MRgFUS alone
1 of 6
Arm E Optimal energy and ALA dose
1 of 6
Arm A Dose-escalation
1 of 6

Experimental Treatment

30 Total Participants · 6 Treatment Groups

Primary Treatment: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) · No Placebo Group · Phase < 1

Arm B Time-escalation
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) · Intervention Types: CombinationProduct
Arm C ALA Dose-escalation
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) · Intervention Types: CombinationProduct
Arm A Energy Dose-escalation
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) · Intervention Types: CombinationProduct
Arm D MRgFUS alone
Device
Experimental Group · 1 Intervention: MR-Guided Focused Ultrasound device (MRgFUS) · Intervention Types: Device
Arm E Optimal energy and ALA dose
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) · Intervention Types: CombinationProduct
Arm A Dose-escalation
CombinationProduct
Experimental Group · 1 Intervention: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Nader SanaiLead Sponsor
6 Previous Clinical Trials
211 Total Patients Enrolled
SonALAsense, Inc.Industry Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
Barrow Neurological InstituteOTHER
19 Previous Clinical Trials
5,837 Total Patients Enrolled
InSightecIndustry Sponsor
86 Previous Clinical Trials
3,512 Total Patients Enrolled
Ivy Brain Tumor CenterOTHER
7 Previous Clinical Trials
238 Total Patients Enrolled
Nader Sanai, MDPrincipal Investigator - St. Joseph's Hospital and Medical Center, Phoenix
Barrow Neurological Institute at St. Joseph's, Chandler Regional Medical Center, Select Specialty Hospital-Phoenix, St. Joseph's Hospital & Medical Center
University Of California (Medical School)
University Ca Sf School Of Medicine (Residency)
9 Previous Clinical Trials
470 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must have experienced progression of a high-grade glioma (grades III and IV) following standard therapy or be at the first recurrence with an unmethylated HGG, having completed prior treatment but not currently scheduled for resection in order to qualify.
A diagnostic biopsy with local pathology review or contrast-enhanced MRI showing positive perfusion must be used to confirm recurrence.
Your arms A-D must have a detectable level of illness prior to the procedure, as indicated by at least one area which enhances contrast imaging with a volume between 6 and 20 cm3 in size.
You must be 18 years or older at the time of consent.
You have a PS rating of 2 or lower on the ECOG scale (Oken et al
You possess sufficient bone marrow and organ capabilities, as attested to by laboratory assessments.
Your absolute neutrophil count is greater than or equal to 1,000/mcL.
Your platelet count at the time of surgery was 100,000/mcL or higher.
You have a minimum hemoglobin level of 8.0 g/dL, and you may receive erythrocyte transfusions to achieve this concentration at the discretion of the investigator.
Your total bilirubin must be no more than 1.5 times the upper limit of normal, although those with Gilbert's syndrome can have an amount up to 2.0 times ULN so long as their direct bilirubin is within standard parameters.