Status:
COMPLETED
Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM
Lead Sponsor:
NovoCure GmbH
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma. ...
Detailed Description
Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obt...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Age ≥ 18 years
- Not a candidate for further radiotherapy or additional resection of residual tumor.
- Patients with first or second radiological disease progression per RANO criteria documented by MRI within 4 weeks prior to starting therapy with the following restriction: disease progression must be either growth of the enhancing lesion or a new lesion.
- Karnofsky performance status ≥ 70
- Life expectancy ≥ least 3 months
- Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
- All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- Treatment start date at least 4 weeks out from brain surgery chemotherapy or irradiation therapy.
Exclusion
- Infratentorial or leptomeningeal disease
- Treatment with Optune® (for newly diagnosed or recurrent disease) prior to enrollment.
- Participation in another clinical treatment study during screening and treatment phase of the study.
- Pregnancy or breast-feeding.
- Significant co-morbidities at baseline, as determined by the investigator:
- Thrombocytopenia (platelet count \< 100 x 103/μL)
- Neutropenia (absolute neutrophil count \< 1 x 103/μL)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
- Total bilirubin \> 1.5 x upper limit of normal
- Significant renal impairment (serum creatinine \> 1.7 mg/dL, or \> 150 µmol/l)
- History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
- Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- Admitted to an institution by administrative or court order.
- Known allergies to medical adhesives or hydrogel
- \-
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04492163
Start Date
July 14 2020
End Date
June 20 2023
Last Update
August 16 2024
Active Locations (1)
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1
Nemocnice Na Homolce
Prague, Czechia, 150 30