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Tests treatment safety and results for Glioblastoma Multiforme
Official title Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)
ClinicalTrials.gov ID: NCT06329570
What this study is testing
What is Lumason?
Lumason is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Also referred to as SonoVue.
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 will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients ≥ 18 years of age at the time of study enrollment.
- Body mass index (BMI) ≥ 17 kg/m2.
- Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging...
- Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study...
- Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual...
You likely can't join if
- Patients who have radiographic evidence of multifocal enhancing tumors.
- Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor...
- Patients who have previously received Carmustine wafers implantation during re-operation.
- Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment
See the full eligibility criteria
Who can join
- Male or female patients ≥ 18 years of age at the time of study enrollment.
- Body mass index (BMI) ≥ 17 kg/m2.
- Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.
- Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.
- Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual tumor ≤ 20 cm3.
- If patients are receiving corticosteroids, they must have been on a stable or decreasing dose of corticosteroids for at least 1 week prior to the planned first treatment.
- At the time of study enrollment, the minimum interval since the last event:
- 4 weeks out from invasive procedures (e.g., open biopsy, surgical resection, significant traumatic injury, or any other major surgery involving entry into a body cavity) and the patient must have recovered from the...
- 1 week out from minor surgical procedures or core biopsies
- Patients must have recovered from the toxic effects of prior therapy at the time of study enrollment as follows:
- 4 weeks out from any investigational drug or device
- 4 weeks out from chemotherapy
- 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., Carmustine (BCNU))
- 12 weeks out from completion of radiotherapy
- Patients should have a life expectancy ≥ 12 weeks.
- Patients must have Karnofsky Performance Status (KPS) ≥ 70.
- Adequate hematopoietic, renal, hepatic, and coagulation function, defined as:
- Hemoglobin ≥ 10 g/dL
- Platelets ≥ 100,000/mm3
- Neutrophils ≥ 1,500/mm3
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
- Urine protein creatinine ratio (UPCR) \< 1 or urine dipstick for proteinuria ≤ 2+
- Alanine aminotransferase (ALT) \< 3 × ULN
- Aspartate aminotransferase (AST) \< 3 × ULN
- Total bilirubin (TBL) \< 2 × ULN
- Prothrombin time ≤ 1.5 x ULN
- International Normalized Ratio (INR) \< 1.5 These tests must be conducted within 2 weeks prior to the planned first treatment.
- The central of FUS exposure region is located close to the cortex, with a minimum distance of at least 30 mm beneath the skull bone.
- Females of childbearing potential must have a negative pregnancy test documented within 2 weeks prior to first treatment. Females of childbearing potential and male patients with partners of childbearing potential must...
- Patients are able and willing to have peripheral intravenous (IV) line placement of Bevacizumab and are able to have hair shaved (either whole head or in the region where the coupling membrane will touch) prior to FUS...
- Patients or their legal representatives are able to provide written informed consent for participation in the trial and patients are willing to comply the procedures (i.e., study-related assessments), instructions, and...
What rules you out
- Patients who have radiographic evidence of multifocal enhancing tumors.
- Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.
- Patients who have previously received Carmustine wafers implantation during re-operation.
- Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment
- Unstable angina pectoris
- Medical history of myocardial infarction within 6 months prior to study enrollment
- Cardiac shunt
- Stroke (except for transient ischemic attack; TIA) within 6 months prior to study enrollment
- Patients with implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator (RNS), deep brain...
- Patients with inadequately controlled hypertension, defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg while on medication, within 2 weeks prior to first treatment.
- Patients with evidence of any thrombotic or hemorrhagic events, including but not limited to:
- Inherited bleeding diathesis or significant coagulopathy with the risk of bleeding (i.e., in the absence of therapeutic anticoagulation).
- History of pulmonary haemorrhage/haemoptysis ≥ grade 2 according to the CTCAE version 5.0 criteria within 1 month prior to study enrollment.
- Arterial or venous thrombosis (e.g., pulmonary embolism) within 6 months prior to study enrollment.
- Patients with unstable pulmonary disease or chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study enrollment.
- Patients who have psychiatric illness/social situations that would limit compliance with study requirements.
- Know HIV-positive patient, however, that HIV testing is not required for entry into this study.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study enrollment.
- History or evidence of active gastroduodenal ulcer, gastrointestinal perforations/fistula, or intra-abdominal abscess within 6 months prior to study enrollment.
- Receiving anticoagulant (e.g., warfarin or LMW heparin) or antiplatelet (e.g., aspirin) therapy within 1 week prior to beginning treatment.
- Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, Lumason® , Avastin® , or any of their components.
- Pregnant (positive pregnancy test) or breast-feeding women.
- Use of any recreational drugs or history of drug addiction.
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled epilepsy, uncontrolled diabetes) that could cause unacceptable safety risks or compromise...
- Any other condition that, in the Investigator's discretion, might increase the risk to the patients or compromise the evaluation of the clinical trial endpoints.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.