Pilot Study of Concomitant NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma

Who is this study for? Patients with newly diagnosed glioblastoma
What treatments are being studied? NovoTTF-200A+Temozolomide+3D conformal or intensity modulated radiation therapy
Status: Completed
Location: See location...
Intervention Type: Device, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is a prospective single arm trial designed to study the safety, feasibility and preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard adjuvant treatment for newly diagnosed glioblastoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed GBM using WHO criteria.

• Age ≥ 18 years

• Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not exclusionary.

• KPS ≥ 70

• Life expectancy of at least 3 months.

• Sexually active participants must agree to the strict use of barrier contraception.

• Patients must be able to understand the investigational nature of the study and provide informed consent.

• Adequate hematologic function:

∙ Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

‣ Platelet count ) ≥ 100 x 109/L

‣ Hemoglobin ≥ 10 g /dL

• Adequate liver function

∙ Total bilirubin ≤ 1.5 x ULN

‣ AST and ALT ≤ 2.5 x ULN

⁃ Adequate renal function

⁃ a. Creatinine ≤ 1.25 x ULN

⁃ International normalized ratio (INR) or PT and activated partial thromboplastin time (aPTT): 1.5 x ULN (except for subjects receiving anticoagulation therapy). Use of anticoagulants is permitted as long as the INR or aPTT are within therapeutic limits (according to the medical standard of the institution).

Locations
United States
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack
Time Frame
Start Date: 2017-07-26
Completion Date: 2022-12-07
Participants
Target number of participants: 12
Treatments
Experimental: NovoTTF-200A + Temozolomide Chemoradiation
NovoTTF-200A, concomitant with radiotherapy and temozolomide, as front-line therapy for glioblastoma
Sponsors
Collaborators: NovoCure Ltd.
Leads: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov