Glioblastoma study: 5-ALA HCl + LIDU SDT
Official title Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT07225621
What this study is testing
What is 5-ALA HCl + LIDU SDT?
This is an investigational combination of a drug and an ultrasound device being studied to treat glioblastoma. It is designed to use ultrasound to activate the drug so it can target tumor cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is checking whether a new ultrasound system combined with the drug 5‑aminolevulinic acid can improve outcomes after standard surgery and chemoradiation for glioblastoma.
- Who it's for
- Adults who have recently been diagnosed with glioblastoma and have finished the usual surgery and chemoradiation treatment.
- What's involved
- Participants will continue their standard oral temozolomide chemotherapy and will be randomly assigned, without knowing which group they are in, to receive either the active ultrasound plus 5‑ALA or a sham ultrasound with a placebo drug.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to...
- ≥ 18 and ≤ 80 years of age
- WHO performance status of ≤ 2 at screening
- Newly diagnosed Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on...
- GBM patients that have an absence of disease progression post craniotomy and TMZ/RT.
You likely can't join if
- Any component of the tumor in the infratentorial location (cerebellar or brainstem tumors are excluded)
- Bihemispheric disease or tumors that involve the bilateral corpus callosum, or disease burden involving the brain stem or cerebellum based on MRI...
- Multi- centric disease (enhancing or non-enhancing) or multi-focal disease (defined as 2 separate areas of contrast enhancement measuring at least 1...
- Leptomeningeal disease
- 6\. A diagnosis of glioscarcoma by histopathology Intent to undergo treatment with the tumor treating fields (TTF) at any time during the study, use...
See the full eligibility criteria
- Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements
- ≥ 18 and ≤ 80 years of age
- WHO performance status of ≤ 2 at screening
- Newly diagnosed Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.
- GBM patients that have an absence of disease progression post craniotomy and TMZ/RT. Note: patients must have undergone prior tumor resection to the extent safely feasible (biopsy only are not eligible).
- 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%...
- Any toxicity attributable to recently completed chemoradiation must be resolved to the patient's baseline level or ≤ Grade 2 (except alopecia or lymphopenia).
- 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.
- Adequate coagulation function defined as PT (prothrombin time)/PTT (partial thromboplastin time) defined as either results within normal institutional values or not considered clinically significant \<1.5 x ULN.
- Non-pregnant, non-lactating females who are postmenopausal, surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation or hysterectomy), or who agree to use effective...
- Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to first 5-ALA administration
- Male patients must be surgically sterile (i.e., 3 months post- vasectomy) or willing to use a highly effective double-barrier contraception method (e.g., male condom with diaphragm or male condom with cervical cap) for...
- No anti-cancer treatment during adjuvant setting after completion of radiation therapy with anything other than temozolomide on Day 2 (+/-1 day) for 5 days per the approved Package Insert (PI).
- Any component of the tumor in the infratentorial location (cerebellar or brainstem tumors are excluded)
- Bihemispheric disease or tumors that involve the bilateral corpus callosum, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement,
- Multi- centric disease (enhancing or non-enhancing) or multi-focal disease (defined as 2 separate areas of contrast enhancement measuring at least 1 cm that are not contiguous and cannot be encompassed in sonication...
- Leptomeningeal disease
- 6\. A diagnosis of glioscarcoma by histopathology Intent to undergo treatment with the tumor treating fields (TTF) at any time during the study, use prior to screening is permitted. 7\.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Albany, New York, United States
- Buffalo, New York, United States
- Long Island City, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Columbus, Ohio, United States
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States; Rochester, Minnesota, United States; Albany, New York, United States; Buffalo, New York, United States; Long Island City, New York, United States; New York, New York, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.