NovoTTF-200A Together With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed GBM

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Mar 8, 2019

Keywords

ClinConnect Summary

Glioblastoma (GBM), a malignant form of astrocytoma, is the most common primary intracranial neoplasm in adults2. The incidence of GBM increases steadily above 45 years of age with a prevalence of approximately 7500 cases in the USA. Despite numerous attempts to improve the outcome of patients with GBM, the 3-year survival of patients treated with maximal surgical resection when feasible, 60 Gy radiotherapy (RT) together with concomitant temozolomide (TMZ) (RT/TMZ), followed by maintenance (adjuvant) TMZ for 6 months was only 6% with median survival of 14.6 months1. In a prospective phase 3...

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Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed diagnosis of GBM according to WHO classification criteria.
• • age ≥ 18 years
• • Recovered from debulking surgery or biopsy-only.
• • Planned treatment with RT/TMZ following maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days)
• • Karnofsky performance status ≥ 70%
• • Life expectancy ≥ least 3 months
• • Participants of childbearing age must use effective contraception.
• • All patients must sign written informed consent.
• • Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.
• Exclusion Criteria:
• • Early progressive disease before initiation of TMZ/RT.
• • Participation in another clinical treatment trial
• • Pregnancy
• * Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator:
• • Thrombocytopenia (platelet count \< 100 x 103/μL)
• • Neutropenia (absolute neutrophil count \< 1.5 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)
• • 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)
• • History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.