An Open Label, Prospective, Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Combination of Focused Ultrasound With Re-irradiation for the Treatment Patients With Recurrent Glioblastoma Multiforme Using NaviFUS System
Overview
- Phase
- Not Applicable
- Intervention
- NaviFUS System
- Conditions
- Recurrent Glioblastoma
- Sponsor
- NaviFUS Corporation
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 19 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult male/female patients ≥ 20 years of age.
- •Patients who meet one of the following criteria are considered eligible: (1) Histologically proven Grade IV glioma patients 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).
- •(2) Histologically proven Grade III glioma patients that is recurrent following radiation therapy (RT) and/or temozolomide, who need re-RT treatment based on the physician's judgment.
- •3\. 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.
- •4\. Minimum interval since completion of radiation treatment is 12 weeks. The targeted region of the radiation treatment must be the same as the targeted region in the study according to the investigator's decision.
- •5\. At the time of study treatment, minimum interval since last drug therapy:
- •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)
- •4 weeks since last cytotoxic therapy or inhibitor of VEGF or VEGFR (e.g., bevacizumab)
- •6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., carmustine \[BCNU\])
- •6\. Body mass index (BMI) ≥17 kg/ m
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 within the previous 6 months, 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) or 2-Deoxy-2-\[18F\]fluoro-D-glucose (FDG); 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.
Arms & Interventions
FUS + re-RT or FUS + SRS
The SRS treatment will be administered for 3 consecutive days (one fraction of 7-9 Gy per day; total dose 21-27 Gy), including SRS treatment 1 (SRS 1), SRS treatment 2 (SRS 2), and SRS treatment 3 (SRS 3). At the SRS 1 and SRS 3, the patients will be shaved their hair at first, and the patient registration will be performed for the neuronavigation system according to the instruction of the system. cRT will be administered for 5 consecutive days within one week, and a full course is two weeks (one fraction of 3-4 Gy per day; total dose: 30-40 Gy), including cRT treatment 1 to cRT treatment 10 (cRT 1-cRT 10). At the cRT 1, cRT 3, cRT 6, and cRT 8, the patients will be shaved their hair at first, and the patient registration will be performed for the neuronavigation system according to the instruction of the system.
Intervention: NaviFUS System
Outcomes
Primary Outcomes
Adverse events
Time Frame: up to 6 months
Safety
Secondary Outcomes
- Quality of life (QoL)(Up to 6 months)
- Progression-free survival (PFS)(Up to 6 months)
- Corticosteroid consumption(Up to 6 months)
- Objective response rate (ORR)(Up to 6 months)
- Overall survival (OS)(Up to 6 months)
- European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)(Up to 6 months)
- European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20)(Up to 6 months)