Clinical Trial 21039

• Overview

  Study Title:

  A Pivotal Randomized, Open-Label Study Of OPTUNE(R)(TTFIELDS, 200KHZ) Concomitant With Radiation Therapy And Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma

  Summary:

  To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

  Objective:

  Primary Objective: To determine if TTFields treatment at 200 kHz to the brain concomitantly with RT and TMZ in the treatment of GBM patients prolongs the overall survival of patients, compared to RT and TMZ treatments followed by TTFields and maintenance TMZ. Secondary Objectives: To determine if TTFields at 200 kHz to the brain concomitant with RT+ TMZ in the treatment of newly diagnosed GBM patients prolongs the progression-free survival of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ To determine if TTFields at 200 kHz to the brain concomitant with RT+ TMZ in the treatment of newly diagnosed GBM patients increases the 1- and 2-year survival rates of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ. To determine if TTFields at 200 kHz to the brain concomitant with RT TMZ in the treatment of newly diagnosed GBM patients improves the overall radiological response rate of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ. To determine if TTFields at 200 kHz to the brain concomitant with RT + TMZ in the treatment of newly diagnosed GBM patients prolongs the next progression-free survival (PFS2) of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ. To determine if TTFields at 200 kHz to the brain concomitant with RT+ TMZ in the treatment of newly diagnosed GBM patients increases the progression-free survival rate at 6 and 12 months, compared to RT + TMZ followed by TTFields + maintenance TMZ. To compare severity and frequency of adverse events of TTFields at 200 kHz to the brain concomitant with RT + TMZ in the treatment of newly diagnosed GBM patients to that of treatment with RT + TMZ followed by TTFields + maintenance TMZ. To describe potential pathological changes in GBM tumors following the treatment of patients treated with TTFields at 200 kHz to the brain concomitant with RT + TMZ followed by TTFields + maintenance TMZ. To compare Quality of Life using the EORTC QLQ C30 (with BN20 module) of TTFields at 200 kHz to the brain concomitant with RT + TMZ in the treatment of newly diagnosed GBM patients to that of treatment with RT + TMZ followed by TTFields + maintenance TMZ. To explore if TTFields at 200 kHz prolongs overall survival in a dose dependent-manner, i.e. to explore the possible connection between higher doses of TTFields at the tumor bed and longer patient survival. NANO scale: To compare neurologic function of TTFields at 200 kHz to the brain concurrent with RT + TMZ in the treatment of newly diagnosed GBM patients to the of treatment with RT + TMZ followed by TTFields + maintenance TMZ using the NANO scale.

• Treatments

  Therapies:

  Chemotherapy (NOS); Radiotherapy

  Medications:

  TTFields (); Temodal (Temozolomide); Temozolomide ()

• Inclusion Criteria

  • Histologically confirmed diagnosis of GBM according to WHO classification criteria.
  • Age > 22 years in US
  • Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
  • Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days)
  • Karnofsky performance status > 70
  • Life expectancy > least 3 months
  • Women of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
  • All participants must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
  • Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.
  • Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
  • Women of childbearing potential must have a negative HCG pregnancy test documented within 14 days prior to randomization.
  • Is able to have MRI with contrast of the brain

• Exclusion Criteria

  • Progressive disease (per investigator's assessment)
  • Infratentorial or leptomeningeal disease
  • Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
  • Pregnancy or breast-feeding.
  • Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator
  • 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.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • Admitted to an institution by administrative or court order.
  • Known allergies to medical adhesives or hydrogel
  • A skull defect (such as, missing bone with no replacement)
  • Prior radiation treatment to the brain for the treatment of GBM
  • Any serious surgical/post-operative condition that may put the patient at risk according to the investigator.
  • Standard TTFields exclusion criteria include: Active implanted medical devices, Bullet fragments, Skull defects

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