OncoMatch/Clinical Trials/NCT07225621
Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
Is NCT07225621 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies 5-ALA HCl + LIDU SDT for glioblastoma.
Treatment: 5-ALA HCl + LIDU SDT — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Performance status
WHO 0–2
Prior therapy
Must have received: surgical resection
patients must have undergone prior tumor resection to the extent safely feasible (biopsy only are not eligible)
Must have received: chemoradiation with temozolomide (temozolomide)
Completion of chemoradiation consisting of radiotherapy (30 x 20 Gy, or equivalent regimen, eg 33 x 18 Gy), with ≥ 90% of the planned radiation therapy dose delivered and concomitant TMZ chemotherapy (75 mg/m2), >66% of the planned doses administered
Cannot have received: any anti-cancer treatment during adjuvant setting after completion of radiation therapy with anything other than temozolomide
No anti-cancer treatment during adjuvant setting after completion of radiation therapy with anything other than temozolomide
Cannot have received: stereotactic radiosurgery
Stereotactic radiosurgery
Cannot have received: Gliadel (carmustine; BCNU) wafers (carmustine)
Placement of Gliadel® (carmustine; BCNU) wafers
Cannot have received: any other intratumoral or intracavity treatment
Any other intratumoral or intracavity treatment
Cannot have received: other chemotherapies, bevacizumab, immunotherapy (including vaccine) or investigational agents (bevacizumab)
Receipt of other chemotherapies, bevacizumab, immunotherapy (including vaccine) or investigational agents
Lab requirements
Blood counts
ANC ≥ 1000 cells/mm3; Platelet count ≥ 50,000 cells/mm3; Hemoglobin (Hgb) ≥ 8 g/dl
Kidney function
Creatinine clearance (CrCl) ≥ 50 ml/min
Liver function
AST/ALT ≤ 5 x ULN; Total bilirubin ≤ 3 x ULN (unless Gilbert's syndrome, then ≤ 5.0 x ULN or direct bilirubin ≤ 3 x ULN)
Adequate bone marrow and organ function, defined by the following laboratory values: A. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 B. Platelet count ≥ 50,000 cells/mm3 C. Hemoglobin (Hgb) ≥ 8 g/dl D. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (ULN) E. Total bilirubin ≤ 3 x ULN (unless gilbert's syndrome, then patients may be eligible if total serum bilirubin is ≤ 5.0 x ULN or direct bilirubin is ≤ 3 x ULN) F. Creatinine clearance (CrCl) as estimated by Cockcroft-Gault equation of ≥ 50 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
- Albany Medical Center · Albany, New York
- Dent Neurologic Institute · Buffalo, New York
- Northwell Health · Long Island City, New York
- New York Langone · New York, New York
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