Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, 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: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Pathological evidence of GBM using WHO classification criteria.

2. > 18 years of age.

3. Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):

1. Patients may enroll in the study if received Gliadel wafers before entering the trial

2. Any additional treatments received prior to enrollment will be considered an exclusion.

3. Minimal dose for concomitant radiotherapy is 45 Gy

4. Karnofsky scale ≥ 70

5. Life expectancy at least 3 months

6. Participants of childbearing age must use effective contraception.

7. All patients must sign written informed consent.

8. Treatment start date at least 4 weeks out from surgery.

9. Treatment start date at least 4 weeks out but not more than 7 weeks from the later of last dose of concomitant Temozolomide or radiotherapy.

Exclusion Criteria:

1. Progressive disease (according to MacDonald Criteria). If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.

2. Actively participating in another clinical treatment trial

3. Pregnant

4. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:

1. Thrombocytopenia (platelet count < 100 x 103/μL)

2. Neutropenia (absolute neutrophil count < 1.5 x 103/μL)

3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)

4. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal

5. Total bilirubin > upper limit of normal

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

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

6. Infra-tentorial tumor

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

8. History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.