Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients

  • STATUS
    Recruiting
  • End date
    Jan 6, 2023
  • participants needed
    8
  • sponsor
    NaviFUS Corporation
Updated on 8 October 2021

Summary

This is an open label, single arm, prospective, and pilot study. Eligible patients will be enrolled after acquiring the signed informed consent and then will receive the treatment of re-RT combined with FUS (FUS + re-RT) on an outpatient basis. The re-RT in FUS + re-RT treatment will include fractioned stereotactic radiosurgery (SRS) treatment (FUS + SRS) or conventional radiotherapy (cRT) treatment (FUS + cRT). The treatment of SRS or cRT treatment given to patients is determined by the investigator depending on the volume and location of the treatment region.

Details
Condition Recurrent Glioblastoma
Treatment NaviFUS System
Clinical Study IdentifierNCT04988750
SponsorNaviFUS Corporation
Last Modified on8 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult male/female patients 20 years of age
Histologically proven glioblastoma multiforme (GBM) that is recurrent following standard radiation therapy (RT) and temozolomide and the second recurrent after prior treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab) administration (bevacizumab failure)
Patients if already on the steroids then should be on a stable or decreasing dose of steroids for at least 7 days prior to study treatment
Minimum interval since completion of radiation treatment is 12 weeks
At the time of study treatment, minimum interval since last drug therapy
(1) 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen), daily
chemotherapy (e.g., metronomic temozolomide, cytoxan) or targeted therapies
administered daily (e.g., gleevec, tarceva)
(2) 4 weeks since last cytotoxic therapy or inhibitor of VEGF or VEGFR (e.g
bevacizumab)
(3) 6 weeks since the completion of a nitrosourea-containing chemotherapy
regimen (e.g., carmustine [BCNU])
\. Body mass index (BMI) 17 kg/ m2
\. Eastern Cooperative Oncology Group (ECOG) score 3
\. Patients with life expectancy 12 weeks
\. Adequate hepatic, renal, coagulation, and hematopoietic function
Hemoglobin 8 g/dL
Platelets 100,000/mm3
Neutrophils 1,500/mm3
Serum creatinine 1.5 x upper limit of normal (ULN)
Alanine transaminase (ALT) < 3 x ULN
Aspartate transaminase (AST) < 3 x ULN
Prothrombin time 1.2 x ULN
International Normalized Ratio (INR) < 1.5
Bilirubin < 2 x ULN
Patients with the region of interest (ROI) for FUS exposure are located at least 30 mm distance beneath the skull bone and the ROI is not in the deep center brain with crucial brain functions, such as in the region of brain stem, or motor or speech regions
Patients with the potential for pregnancy and their partner must agree to follow acceptable birth control methods to avoid conception. Female patients of child-bearing potential must have a negative pregnancy test
Able to give written informed consent for the participation in the trial and comply with study requirements in the opinion of the investigator

Exclusion Criteria

Patients with implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias
Patients with meningeal metastasis, intracranial stroke, congestive heart failure, unstable angina, cardiac arrhythmia, unstable cardiac status, and uncontrolled seizure activity
Patients with known HIV, however, that HIV testing is not required for entry into this study
Any patient requiring supplemental oxygen therapy
Use of any recreational drugs or history of drug addiction
Pregnant or breast-feeding women
The receipt of an investigational drug within a period of 28 days prior to the first FUS exposure
Known sensitivity/allergy to PET tracers, O-(2- [18F]fluoroethyl)- L-tyrosine (FET); Magnetic Resonance Imaging (MRI) contrast agents, Dotarem; Computer Tomography (CT) contrast agents; SonoVue; or any of its components
Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
Patients who have acute hemorrhage within the ROI
Major surgery or significant traumatic injury that has not been recovered from by 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device 1 week prior to screening, or who have not recovered from side effects of such procedure or injury
Patients who have coagulopathy or risk factors for bleeding
Receiving anticoagulants or antiplatelet drugs within one week before study entry
Receiving medications known to increase the risk of bleeding within one month before study entry (e.g., bevacizumab)
Contraindications to MRI, including but not limited to metallic implants and claustrophobia
Patients with severe hypertension (defined as systolic blood pressure > 180 mmHg or diastolic blood pressure >100 mmHg)
Patients with cardiac shunt
Patients with anticancer therapy-related adverse events which are unrecovered/unresolved to baseline or at grade 1 in severity
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