Enhancing Optune Therapy With Targeted Craniectomy

Glioblastoma Clinical Trial

Official title:

Enhancing Optune Therapy of Recurrent Glioblastoma Multiforme Using Targeted Surgical Skull Remodeling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893137
• Other study ID #: 54762
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study proposes a new and potentially superior clinical approach to Optune™ therapy of selected glioblastoma patients. The approach is based on combining TTFields with targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr holes, designed for the individual patient. Pre-clinical modeling results suggest that such procedures may enhance the induced electrical field strength by up to ~100% and thereby potentially improve the clinical outcome of treated patients to a significant extent.

The study is an open label phase 1 clinical pilot experiment designed to investigate feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of glioblastoma will be included in the trial. All patients will receive TTFields therapy with targeted craniotomy and best physician's choice chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathological evidence of GBM using WHO classification criteria

• Estimated survival minimum three months

• Supratentorial tumor

• Not a candidate for further radiotherapy

• First disease recurrence in accordance with RANO criteria

• Karnofsky scale score minimum 70

• Ability to comply with Optune therapy

• Tumor characteristics which indicate significant expected benefit from feasible craniotomy or skull remodelling surgery combined with TTFields

• Focal tumor

• Most superficial border of tumor or resection cavity closer than 2 cm from brain surface

• Use of validated anti-conception for female participants in accordance with guidelines provided by the Danish Health and Medicines Authority

• Signed written consent form

Exclusion Criteria:

• Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy

• Less than four weeks since radiation therapy

• Infratentorial tumor

• Implanted pacemaker, programmable shunt, defibrillator, deep brain stimulator, other implanted devices in the brain, or documented clinically significant arrhythmias.

• Uncontrollable symptomatic epilepsy, refractory to standard medication. Epilepsy will not necessarily contraindicate participation in the trial as this is a common complication to the disease. Eligibility will be determined by the examining physician and investigators in conjunction upon careful consideration of patient safety.

• Contraindications for skull remodelling surgery, e.g. bleeding diathesis or severe infection.

• Significant co-morbidities (within four weeks prior to enrolment)

• Significant liver function impairment - ALT > 3 times the upper limit of normal

• Total bilirubin > upper limit of normal

• Significant renal impairment (serum creatinine > 1.7 mg/dL)

• Coagulopathy (as evidenced by PT or APTT > 1.5 times control in normal individuals not undergoing anticoagulation)

• Thrombocytopenia (platelet count < 100x10^3/µL )

• Anemia (Hb < 10 g/L)

• Active participation in another clinical treatment trial

Patients will be regarded as participants when they have signed a consent form and have been found suitable for enrolment by the examining physician, in accordance with the abovecriteria. Patients may receive medication depending on their clinical condition and other diseases.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Device:
• Optune
For further information see www.optune.com

Procedure:
• Craniectomy
A small hole is placed in the skull between the tumor and the closest Optune electrode. The position and geometry of the craniotomy is determined by computersimulation of the electric field induced by Optune therapy. Craniotomy is a surgical procedure, which is carried out under general anaesthesia.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	NovoCure Ltd.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of serious adverse events	Based on CTCAE.	Through study completion, an average of 18 months.
Secondary	Overall survival		Through study completion, an average of 18 months.
Secondary	Progression free survival		Through study completion, an average of 18 months.
Secondary	Progression free survival at six months		Through study completion, an average of 18 months.
Secondary	% 1-year survival		Through study completion, an average of 18 months.
Secondary	Objective response rate	Assessed by RANO criteria	Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Secondary	Quality of life	Assessed by EORTC QLQ-30 and QLQ-BN20	Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Secondary	Cumulative corticosteroid dosage		Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Secondary	Karnofsky performance score		Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.