Glioblastom WHO Grade 4 study: 5-ALA
Official title TMZ + RT + 5-ALA + LIDU SDT System for Newly Diagnosed Butterfly Glioma
ClinicalTrials.gov ID: NCT07862647
What this study is testing
What is 5-ALA?
an investigational oral drug being studied for safety and tolerability in patients with newly diagnosed glioblastoma (WHO Grade 4) undergoing PoMA with LIDU ultrasound. is designed to increase tumor cell production of porphyrin metabolites that can be activated by ultrasound during PoMA.
Also referred to as 5-aminolevulinic acid.
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
- This study checks if a new treatment using a special light and a drug is safe and well-tolerated.
- Who it's for
- People who have just been diagnosed with glioblastoma affecting both sides of the brain.
- What's involved
- Participants will receive a new treatment that uses ultrasound and light to activate a drug, along with their standard care.
- Time commitment
- The study covers the time before, during, and after standard radiation and chemotherapy.
- Phase 1: an early, usually small safety study
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, or the patient's legally authorized representative, must provide informed consent, stating understanding of the procedures and...
- ≥ 18 and ≤ 80 years of age
- WHO performance status of ≤ 2 at screening
- Newly diagnosed histologically proven glioblastoma (WHO criteria 2021), with absence of IDH mutation demonstrated by negative IDH1 R132H staining on...
- Patients must have a radiographic butterfly glioma phenotype on MRI, defined as a contiguous enhancing glioma involving both cerebral hemispheres...
You likely can't join if
- Any component of the tumor in the infratentorial location (cerebellar or brainstem tumors are excluded)
- Commencing TMZ + RT per SOC before the first SDT treatment
- Leptomeningeal disease
- Corticosteroid use \> 4 mg/day of dexamethasone (or equivalent), steroid dose should be stable or decreasing for ≥1 week prior to randomization
- Inability to undergo MRI or receive gadolinium (Gd)-based contrast agents
- Hypersensitivity to 5-ALA or porphyrins
See the full eligibility criteria
- Patient, or the patient's legally authorized representative, must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study...
- ≥ 18 and ≤ 80 years of age
- WHO performance status of ≤ 2 at screening
- Newly diagnosed histologically proven glioblastoma (WHO criteria 2021), with absence of IDH mutation demonstrated by negative IDH1 R132H staining on immunohistochemistry or equivalent molecular testing.
- Patients must have a radiographic butterfly glioma phenotype on MRI, defined as a contiguous enhancing glioma involving both cerebral hemispheres with midline extension through the corpus callosum (genu, body, and/or...
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
- Platelet count ≥ 50,000 cells/mm3
- Hemoglobin (Hgb) ≥ 8 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN (unless gilbert's syndrome, then patients may be eligible if total serum bilirubin is ≤ 3.0 x ULN or direct bilirubin is ≤ 1.5 x ULN)
- Creatinine clearance (CrCl) as estimated by Cockcroft-Gault equation of ≥ 50 mL/min
- 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)...
- Any component of the tumor in the infratentorial location (cerebellar or brainstem tumors are excluded)
- Commencing TMZ + RT per SOC before the first SDT treatment
- Leptomeningeal disease
- Corticosteroid use \> 4 mg/day of dexamethasone (or equivalent), steroid dose should be stable or decreasing for ≥1 week prior to randomization
- Inability to undergo MRI or receive gadolinium (Gd)-based contrast agents
- Hypersensitivity to 5-ALA or porphyrins
- Patient head size \> 16.6 cm in breadth (max width of head, above the ears) and \> 21.3 cm in length (front to back) to ensure fit within the helmet transducer array.
- Skull voids/defects \> 10 mm diameter if defect is open, or \> 14 mm if defect is covered with titanium burr hole cover, titanium mesh, or similar repair hardware.
- Hemorrhagic or ischemic stroke (including transient ischemic attacks) and central nervous system bleeding in the preceding 6 months that are not related to glioma surgery.
- Has any history of glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder...
- Patients who have clinically significant cerebral edema requiring urgent intervention (e.g., surgery, unstable or escalating high doses of steroids).
- Patients with rapid clinical deterioration that, in the opinion of the investigator, is likely to worsen during the first cycle of treatment.
- Acute or chronic types of porphyria.
- Gastrointestinal disorder that negatively affects absorption.
- Known active hepatitis B or C (Note: testing is not required).
- Known human immunodeficiency virus (HIV) infection (Note: testing is not required).
- Participation in another treatment clinical trial for butterfly glioma/GBM. (Observational studies are allowable)
- Unable to avoid phototoxic drugs (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones, and tetracyclines) for 24 hours prior to and following 5-ALA...
- Any other concurrent severe or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, cardiac disease, clinically significant...
- Women who are pregnant or breastfeeding
- Patients with a condition the Investigator believes would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.
The study team makes the final eligibility decision.
Where it is enrolling
- Buffalo, New York, 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 Buffalo, New York, United States. 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.