TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, single arm open label study, designed to test the to evaluate the tolerability and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to Radiotherapy/Temozolomide followed by Temozolomide. The device is a portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovoCure Ltd.
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of GBM according to WHO classification criteria.

2. Supratentorial tumor location

3. Age ≥ 18 years

4. Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)

5. Planned standard adjuvant chemoradiotherapy of approx. 60 Gy of Radiotherapy (RT), or biologically equivalent dose, according to local practice, and concomitant Temozolomide (TMZ) chemotherapy (75mg/m^2 daily). Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered an exclusion.

6. Planned treatment with adjuvant/maintenance TMZ (150-200 mg/m^2 daily x 5 d, q28 days)

7. Karnofsky performance status ≥ 70

8. Life expectancy ≥ 3 months

9. Participants of childbearing age must use effective contraception.

10. All patients must sign written informed consent.

11. NovoTTF-200A treatment start date at least 2 weeks out from brain surgery.

12. NovoTTF-200A treatment start prior to or at the beginning of RT/TMZ

13. Stable or decreasing dose of corticosteroids for the last 7 days prior to enrollment, if applicable.

Exclusion Criteria:

1. Participation in another clinical treatment trial

2. Pregnancy or breast feeding

3. Significant co-morbidities at baseline which would preclude TMZ treatment

4. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.

5. Infra-tentorial tumor location

6. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)

7. History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.

8. Known allergies to medical adhesives or gel