Actively Recruiting
Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
Led by Alpheus Medical, Inc. · Updated on 2026-03-19
103
Participants Needed
8
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.
CONDITIONS
Official Title
Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent and willing to follow study procedures
- Age between 18 and 80 years
- WHO performance status of 2 or less at screening
- Newly diagnosed glioblastoma confirmed by histology without IDH mutation
- No disease progression after surgery and chemoradiation with temozolomide
- Completed chemoradiation with at least 90% of planned radiation and over 66% of temozolomide doses
- Any side effects from chemoradiation resolved to baseline or mild (Grade 2 or less) except hair loss or low lymphocytes
- Adequate bone marrow and organ function based on blood tests
- Normal or acceptable blood clotting function
- For females: non-pregnant, non-lactating, postmenopausal, surgically sterile, or agree to use effective contraception
- Negative pregnancy test within 7 days before first 5-ALA dose for women of childbearing potential
- For males: surgically sterile or agree to use effective double-barrier contraception during study and 30 days after
- No other anti-cancer treatments except temozolomide after radiation therapy
You will not qualify if you...
- Tumor located in brainstem, cerebellum, infratentorial area, or involving both brain hemispheres
- Multicentric or multifocal brain tumor disease not suitable for ultrasound treatment
- Leptomeningeal disease
- Diagnosis of gliosarcoma
- Plan to use tumor treating fields therapy during the study
- Use of corticosteroids over 4 mg/day dexamethasone or equivalent at randomization
- Unable to have MRI with gadolinium contrast
- Allergy to 5-ALA or porphyrins
- Head size too large to fit study device
- Skull defects larger than allowed size
- Recent stroke or brain bleeding within 6 months unrelated to surgery
- History of other cancers within 3 years except certain skin or bladder cancers
- Severe brain swelling needing urgent treatment
- Rapid worsening condition expected to decline during first cycle
- Prior glioma treatments other than surgery and chemoradiation with temozolomide
- Acute or chronic porphyria
- Gastrointestinal issues affecting drug absorption
- Active hepatitis B or C
- Known HIV infection
- Participating in another interventional glioblastoma trial
- Unable to avoid certain phototoxic drugs around 5-ALA administration
- Other severe uncontrolled medical conditions
- Pregnant or breastfeeding women
- Unable to provide informed consent or comply with the study protocol
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
3
Dent Neurologic Institute
Buffalo, New York, United States, 14226
Actively Recruiting
4
Northwell Health
Long Island City, New York, United States, 11030
Actively Recruiting
5
New York Langone
New York, New York, United States, 10016
Not Yet Recruiting
6
Columbia University
New York, New York, United States, 10032
Actively Recruiting
7
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
8
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
A
Ann-Marie VP, Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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