Clinical Trials /

HUMC 1612: Optune NovoTTF-200A System

NCT03128047

Description:

The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely used in combination with chemotherapy in pediatric patients with recurrent high-grade glioma and ependemoma.

Related Conditions:
  • Anaplastic Astrocytoma
  • Anaplastic Ependymoma
  • Astroblastoma
  • Ependymoma
  • Glioblastoma
  • Gliosarcoma
  • Malignant Glioma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: HUMC 1612: Optune NovoTTF-200A System
  • Official Title: HUMC 1612: A Phase I Trial of the Optune NovoTTF-200A System With Concomitant Temozolomide and Bevacizumab in Pediatric Patients With High-grade Glioma

Clinical Trial IDs

  • ORG STUDY ID: Pro2016-0583
  • NCT ID: NCT03128047

Conditions

  • High Grade Glioma
  • Ependymoma

Purpose

The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely used in combination with chemotherapy in pediatric patients with recurrent high-grade glioma and ependemoma.

Detailed Description

      This phase I trial will utilize a standard 3+3 design to determine the safety and
      tolerability of the Optune NovoTTF-200A System in pediatric patients with recurrent
      high-grade glioma end ependemomas.

      Patients will receive treatment with the Optune NovoTTF-200A System along with Temozolomide
      and Bevacizumab and will consist of children with recurrent high-grade gliomas and
      Ependamomas. Patients enrolled will receive treatment with the Optune NovoTTF-200A with
      200kHz for a minimum of 18 hours per day in 28 day cycles as monotherapy. Phase I safety
      evaluation will take place over the initial two cycles (56 days) of treatment. Following the
      completion of the safety evaluation period, patients will continue to receive treatment in 28
      day cycles, which may be repeated continuously without therapy interruption for 12 cycles or
      until clinical criteria for discontinuation are met. Patients how appear to benefit from this
      treatment may be allowed to continue treatment beyond 12 cycles if approved by the study
      Principle Investigator.
    

Trial Arms

NameTypeDescriptionInterventions
Recurrent high grade gliomas and ependymomasExperimentalRecurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Patients must have a minimum head circumference of 44 cm
    
              -  Patients must have a histologically- or cytologically-confirmed supratentorial
                 high-grade glioma or supratentorial ependemoma.
    
              -  Patients with metastatic disease involving the infratentorium or spinal cord are
                 eligible providing that they have a supratentorial tumor that is able to be targeted
                 with TTFields.
    
              -  Eligible pathologic diagnoses include:
    
            High-grade Glioma (WHO Grade III or IV): Anaplastic Astrocytoma, Astroblastoma, Diffuse
            Midline Glioma, Glioblastoma, Gliosarcoma Ependymoma (WHO Grade II or III):Ependymoma,
            Anaplastic Ependymoma
    
              -  Patients with high-grade glioma must must have be newly-diagnosed or have a tumor that
                 is progressive or recurrent following standard treatment. Patients with ependymoma
                 must have a tumor that is progressive or recurrent following standard treatment.
    
              -  Patients must have received the maximal feasible resection of their tumor and
                 radiation therapy (unless contraindicated due to patient age) as part of their initial
                 treatment prior to study enrollment.
    
              -  Patients must be enrolled before treatment begins. Treatment must start within 14 days
                 of study enrollment.
    
              -  All clinical and laboratory studies to determine eligibility must be performed within
                 7 days prior to enrollment unless otherwise indicated in the eligibility section.
    
              -  Newly-diagnosed patients must begin therapy within six weeks of the completion of
                 radiotherapy, or within six weeks of surgical resection if radiotherapy is
                 contraindicated.
    
              -  Recurrent high-grade glioma patients must begin therapy within four weeks of
                 documented tumor progression by MRI scan.
    
              -  Patients must have a Lansky or Karnofsky performance status score of ≥ 50%,
                 corresponding to ECOG categories of 0, 1 or 2. Use Karnofsky for patients > 16 years
                 of age and Lansky for patients ≤ 16 years of age. Patients who are unable to walk
                 because of paralysis, but who are up in a wheelchair will be considered ambulatory for
                 the purpose of assessing the performance score.
    
              -  Able to undergo adequate tumor imaging, via magnetic resonance imaging (MRI) scan to
                 evaluate disease evolution.
    
              -  Adequate hematologic, renal, liver function as demonstrated by laboratory values: ANC
                 ≥ 1,000/ul Hemoglobin ≥8.0 gm/dl Platelet count ≥ 100,000/ul
    
            Adequate Liver Function Defined As:
    
              -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and
    
              -  SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age. Adequate Renal Function
                 Defined As Either
    
              -  Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2
    
              -  or a serum creatinine less than or equal to the institutional normal for age
    
                   -  Negative pregnancy test in women of childbearing potential within 7 days of
                      initiating investigational therapy
    
                   -  Recent mothers must agree not to breast feed while receiving medications on study
    
                   -  Patient or legal guardian must give written, informed consent or assent (when
                      applicable).
    
                   -  Able to swallow and ingest oral medication or have a NG or G-tube for drug
                      administration
    
                   -  Urine protein should be screened by urine analysis. If protein ≥ 2+ on
                      urinalysis, then Urine Protein Creatinine (UPC) ratio should be calculated. If
                      UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be
                      < 1000 mg for patient enrollment.
    
            Note: UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC
            ratio of 1 is roughly equivalent to a 24-hour urine protein of 1000 mg. UPC ratio is
            calculated using one of the following formula:
    
              -  [urine protein]/[urine creatinine] - if both protein and creatinine are reported in
                 mg/dL
    
              -  [(urine protein) x0.088]/[urine creatinine] - if urine creatinine is reported in
                 mmol/L
    
              -  Adequate Coagulation Defined As: PT/INR ≤ 1.5 x upper limit of normal
    
            Exclusion Criteria:
    
              -  Age less than 5 or greater than or equal to 18 years
    
              -  Head circumference < 44 cm
    
              -  Absence of supratentorial tumor
    
              -  Use of any other investigational drug within five half-lives of that drug prior to the
                 initiation of protocol therapy
    
              -  Anti-cancer therapy within 4 weeks prior to the initiation of protocol therapy (6
                 weeks for mitomycin and nitrosureas, 4 weeks for curative-intent radiotherapy, and 2
                 weeks for palliative radiotherapy)
    
              -  Any National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE
                 version 4.0) >Grade 1 toxicities from prior chemotherapy or radiotherapy that could
                 impact on safety outcome assessment
    
              -  Any surgery within 14 days prior to initiation of protocol therapy (excluding shunt or
                 line insertion)
    
              -  Implanted pacemaker, programmable shunts, 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)
                 Patients receiving escalating doses of corticosteroids to control symptoms of
                 increased intracranial pressure (e.g., require a stable or decreasing dose of
                 corticosteroids for at least 7 days prior to enrollment) will also be excluded.
    
              -  Known > Grade 1 intracranial or intratumoral hemorrhage either by CT or MRI scan
                 within the last 1 month. Patients with resolving hemorrhage changes, punctuate
                 hemorrhage or hemosiderin may enter the study
    
              -  Pregnant female patients, Pregnancy tests with a negative result must be obtained in
                 all post-menarchal females.
    
              -  Lactating females must agree they will not breastfeed a child while on this study.
    
              -  Males and females of reproductive potential may not participate unless they agree to
                 use an effective contraceptive method and continue to do so for at least 6 months
                 after the completion of therapy.
    
              -  Any serious and/or unstable pre-existing medical, psychiatric or other condition which
                 in the Investigator's opinion could interfere with subject safety, obtaining written
                 informed consent, or compliance with the study protocol
    
              -  Known hypersensitivity to temozolomide or bevacizumab
    
              -  Patients who are unable to take oral medications because of significant uncontrolled
                 vomiting will be excluded.
    
              -  Patients must not have a history of myocardial infarction, severe or unstable angina,
                 clinically significant peripheral vascular disease, Grade 2 or greater heart failure,
                 or serious and inadequately controlled cardiac arrhythmia.
    
              -  Patients must not have a known clinically significant bleeding diathesis or
                 coagulopathy
    
              -  Patients who have experienced arterial thromboembolic events, including transient
                 ischemic attacks or cerebrovascular accidents are excluded from participation.
    
              -  Patients must not have been previously diagnosed with a deep venous thrombosis
                 (including pulmonary embolism), and must not have a known thrombophilic condition
                 (e.g., protein S, protein C, antithrombin III deficiency, Factor V Leiden or Factor II
                 G202`0A mutation, homocysteinemia, or antiphospholipid antibody syndrome).
    
              -  Patients must not have a history of an abdominal fistula, gastrointestinal
                 perforation, or intra-abdominal abscess within the last 6 months prior to study entry.
    
              -  Patients with a serious or non-healing wound, ulcer, or bone fracture are not eligible
                 for this study.
    
              -  Patients with a history of allergic reaction to Chinese hamster ovary cell products,
                 or other recombinant human antibodies are ineligible.
          
    Maximum Eligible Age:21 Years
    Minimum Eligible Age:5 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Safety of the Optune NovoTTF-200A System when used alone in pediatric patients with recurrent high-grade gliomas.
    Time Frame:56 Days
    Safety Issue:
    Description:Number of participants receiving treatment with the Optune NovoTTF-200A System with treatment-related adverse events as assessed by CTCAE v4.0.

    Secondary Outcome Measures

    Measure:Assess the progression free of patients treated on this study protocol to aid in the future development of pediatric phase II/III studies using the Optune NovoTTF-200A System.
    Time Frame:Up to 2 years after study entry
    Safety Issue:
    Description:Number of events
    Measure:Assess the overall survival of patients treated on this study protocol to aid in the future development of pediatric phase II/III studies using the Optune NovoTTF-200A System.
    Time Frame:Up to 2 years after study entry
    Safety Issue:
    Description:Number of events

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Hackensack Meridian Health

    Trial Keywords

    • pediatric cancer
    • brain tumor
    • glioblastoma
    • high grade brain tumor
    • malignant brain tumor
    • recurrent brain tumor

    Last Updated

    June 3, 2020