Your session is about to expire
← Back to Search
Procedure
Sonodynamic Therapy for Glioblastoma
Phase 1 & 2
Waitlist Available
Led By Stuart Marcus, MD, PhD
Research Sponsored by SonALAsense, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be 18 years or older at the screening visit
Histologically proven GBM that has recurred or progressed, and for which resection is not indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment called sonodynamic therapy (SDT) to see if it is safe and effective in people with brain tumors.
Who is the study for?
Adults with recurrent glioblastoma (GBM) who've had standard treatments and have a tumor volume of 5-30 mL. They must be stable on steroids if used, have good organ function, and a Karnofsky Performance Score over 70. Participants need to agree to effective birth control and not have certain medical conditions or recent treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing SONALA-001 combined with MR-Guided Focused Ultrasound (MRgFUS) for safety, tolerable dosages, and early signs of effectiveness in treating GBM. It aims to find the best dose for future studies after one treatment session using this sonodynamic therapy approach.See study design
What are the potential side effects?
Potential side effects are not detailed but may include reactions related to the drug SONALA-001 or issues from focused ultrasound like discomfort at the treatment site. Side effects will be monitored closely to determine safe dosage levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My glioblastoma has returned or worsened and surgery isn't an option.
Select...
I am not pregnant and will use effective birth control during the trial.
Select...
I am mostly able to care for myself but may not be able to do active work.
Select...
I have been treated with radiotherapy and temozolomide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival rate at 6 Months (Phase 2)
Safety and Tolerability of SONALA-001 SDT as assessed by the frequency and severity of dose-limiting toxicities (DLTs)
Safety and Tolerability of SONALA-001 SDT as assessed by the number of subjects with Adverse Events (AEs), adverse device effects (ADEs), serious AEs (SAEs) and serious device effects (SADEs)
+3 moreSecondary outcome measures
To evaluate preliminary efficacy and Duration of Clinical Benefit (DOCB) (Phase 2)
To evaluate preliminary efficacy and Duration of Response (DOR) (Phase 1)
To evaluate preliminary efficacy and Overall Survival (OS) (Phase 1)
+12 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment1 Intervention
Recommended Phase 2 Dose (RP2D) IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 5
Group II: Cohort 4Experimental Treatment1 Intervention
10 mg/kg IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 4
Group III: Cohort 3Experimental Treatment1 Intervention
10 mg/kg IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 3
Group IV: Cohort 2Experimental Treatment1 Intervention
10 mg/kg IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 2
Group V: Cohort 1Experimental Treatment1 Intervention
10 mg/kg IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 1
Find a Location
Who is running the clinical trial?
SonALAsense, Inc.Lead Sponsor
3 Previous Clinical Trials
470 Total Patients Enrolled
Stuart Marcus, MD, PhDPrincipal InvestigatorSonALAsense, Inc.
9 Previous Clinical Trials
1,126 Total Patients Enrolled
Corina Andresen, MDStudy DirectorSonALAsense, Inc.
2 Previous Clinical Trials
79 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My glioblastoma has returned or worsened and surgery isn't an option.My steroid dosage has been stable or decreasing for the last 7 days.I have no other cancer besides the one being treated in this study.My cancer has not returned within 4 weeks after finishing radiotherapy.My white blood cell count is high enough without recent growth factor drugs.My organs and bone marrow are functioning well.My cancer did not come back within 3 months after finishing radiotherapy.I have not had radiation therapy in the last 4 weeks.My MRI shows a single growing brain tumor between 5 and 30 mL.I've had standard brain cancer treatment with radiation and, if applicable, temozolomide.I have been diagnosed with porphyria.My neurological condition has worsened significantly in the last week.I haven't had specific brain tumor treatments like Gliadel or Optune in the last 4 weeks.I have had up to two treatments for my cancer that came back or got worse.I still have side effects from cancer treatment that are not mild.I haven't taken blood thinners in the last week.I have not had major surgery in the last 3 weeks.My corticosteroid dose has been stable or decreasing for the last week.I have not had cancer treatment within the specified time.My cancer is located in the brainstem or is diagnosed as gliomatosis cerebri.I haven't used any substances that increase sun sensitivity 24 hours before or after treatment.I understand and agree to follow the study's procedures and rules.My tumor is in the upper part of my brain or cerebellum.I am not pregnant and will use effective birth control during the trial.I am mostly able to care for myself but may not be able to do active work.I have been treated with radiotherapy and temozolomide.My brain tumor is a type of GBM that has come back or gotten worse and surgery isn't an option.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
- Group 5: Cohort 5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total count of participants that have been enrolled in this clinical trial?
"Indeed, clinicaltrials.gov presently displays that this medical trial is actively recruiting people to participate. First published on September 1st 2022 and most recently amended on the 29th of the same month, 50 individuals are being sought from two distinct locations."
Answered by AI
Are recruitment efforts currently underway for this experiment?
"Affirmative. According to clinicaltrials.gov, this investigation is currently looking for participants having first been listed on September 1st 2022 and most recently updated on the 29th of that same month. 50 patients need to be recruited from two different medical centres."
Answered by AI
Has Cohort 9 been granted authorization by the Food and Drug Administration?
"Our evaluation of Cohort 9's safety has granted it a score of 2, as the trial is in its second phase with some data indicating that the intervention may be safe but no evidence yet to suggest efficacy."
Answered by AI
What ambitious goals is this experiment aiming to accomplish?
"This clinical trial's primary outcome, assessed from Day 1 until Day 29, is Progression-free survival rate at 6 Months (for the Expansion Cohort). Secondary outcomes of interest include Area under the plasma concentration vs time from Time 0 to the last measurable timepoint (AUC0-t) and Maximum drug concentration (Tmax), both determined through sampling 10 times over 24 hours prior and after SONALA-001 administration. Additionally, Elimination Rate Constant of ALA in blood plasma will be tracked using similar methodology."
Answered by AI
Who else is applying?
What site did they apply to?
UCSF
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger