Status:
RECRUITING
Sonodynamic Therapy in Patients With Recurrent GBM
Lead Sponsor:
Shayan Moosa, MD
Conditions:
Recurrent Glioblastoma
Glioblastoma Multiforme
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Patients diagnosed with glioblastoma (GBM) are faced with limited treatment options. This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with ne...
Detailed Description
The combination of 5-ALA (Gleolan) and LIFU is collectively known as sonodynamic therapy (SDT). SDT is an investigational therapy that will be administered 1-3 weeks before surgery for recurrent GBM. ...
Eligibility Criteria
Inclusion
- Disease status and Disease Parameters:
- Suspected recurrent glioblastoma that is clearly measurable based on the modified Response Assessment in Neuro-Oncology (RANO) criteria
- The tumor lesion needs to comprise at least 1 contrast-enhancing lesion with a volume of ≥ 2 cm3 and ≤ 20 cm3 of targeted treatment area
- Tumor tissue to be treated is in a surgically accessible brain region for resection
- The brain tumor to be treated must be in the treatment envelope of the NaviFUS system (30 mm to 90 mm from the inner skull table)
- Recurrence will be assessed by imaging and confirmed by consensus at tumor board
- Men or women between the ages of 18-80 years of age at the time of consent
- No contraindication to repeat brain surgery
- Karnofsky Performance Score of 70-100
- Able to undergo an MRI with contrast
- Able to swallow oral medications
- Willingness and ability to comply with scheduled visits, treatment plans, lifestyle considerations, laboratory tests, and other procedures.
- Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
- Participants who received prior chemotherapy, radiation therapy, immunotherapy, and/or another investigational therapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1 or baseline) from the acute effects of the therapy or therapies) except for residual alopecia or Grade 2 peripheral neuropathy prior to registration.
- Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
- Hematological
- Absolute neutrophil count (ANC) ≥1000/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 11 g/dL for women and ≥ 12 g/dL for men Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
- INR ≤ 1.4
- Renal \& Hepatic
- Creatinine clearance CrCl ≥ 60 mL/min/1.73 m2 as estimated by the Cockcroft-Gault (C-G) equation. If estimated CrCl is abnormal, accurate measurement should be obtained by 24- hour CrCl.
- Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 2.0x ULN is allowed).
- AST and ALT ≤ 3 x ULN
- Alkaline phosphatase ≤ 3 x ULN
- Estimated glomerular filtration rate ≥30mL/min/1.73m2
Exclusion
- Known sensitivity or allergy to 5-ALA
- Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- Diagnosis of porphyria
- Hypersensitivity against porphyrins
- Pregnancy
- Significant cardiac disease or coagulopathy
- Herniation / intractable seizure / other clinical indications requiring urgent resection
- Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive)
- Have had a recent (≤3 months prior to registration) transient ischemic attack or stroke
- Significant vascular disease (e.g. aortic aneurysm)
- Evidence of bleeding diathesis or coagulopathy
- Need for systemic anticoagulation which cannot be held for 7 days prior to SDT
- Unstable angina and/or congestive heart failure (NYH Class III or Class IV; see section 13.2) within 6 months prior to registration
- Severe hypertension (systolic ≥ 180 mm Hg; diastolic ≥ 120 mm Hg) despite anti-hypertensive medications
- Transmural myocardial infarction within 6 months prior to registration
- Serious and inadequately controlled cardiac arrhythmia
- Acute exacerbation of chronic obstructive pulmonary disease
- Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
- Treatment with another investigational drug or investigational procedure within 30 days prior to registration or within 5 half-lives of the investigational product, whichever is longer
- Brain edema and/or mass effect that causes midline shift of more than 15 mm
- Evidence of recent (within 30 days prior to registration) intracranial hemorrhage
- Calcifications or metallic implanted objects in the focused ultrasound sonication path
- Scalp atrophy or scars at the expected location of transducer
- Cerebral or systemic vasculopathy
- Need for or currently on dialysis
- Respiratory: chronic pulmonary disorders (e.g., severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area).
- Receipt of radiotherapy ≤21 days prior to registration
- Receipt of chemotherapy ≤ 21 days prior to registration
- Prior treatment with sonodynamic therapy
- Concurrent use of Optune device
- Concurrent use of supplements or medications with substantial antioxidant effects (including sulfhydryl-containing medications such as captopril or supplements such as N-acetylcysteine, or high doses of vitamins with antioxidant activity such as C or E)
- Known sensitivity to gadolinium
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06039709
Start Date
January 31 2024
End Date
June 1 2026
Last Update
December 9 2024
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903