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Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma

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ClinicalTrials.gov Identifier: NCT03033992
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pediatric Brain Tumor Consortium

Brief Summary:
This feasibility trial studies how well the Optune device works in treating younger patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. The TTFields generated by Optune device may inhibit the growth of tumor.

Condition or disease Intervention/treatment Phase
Malignant Glioma Ependymoma Device: Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields) Not Applicable

Detailed Description:

Primary Objectives:

I To establish the feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.

II To describe the Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.

Secondary Objectives:

I To estimate the response rate and Event-Free Survival (EFS) as markers of anti-tumor activity of the Optune device within the context of a feasibility trial.

II To assess the association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study.

III To explore the impact of the Optune device on the children and families undergoing this therapy, and to explore the association between demographic (e.g., SES, gender), disease (e.g., risk status), treatment, and behavioral variables with health-related quality of life (QoL) changes.

IV To explore the association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS.

Outline:

The Optune will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Cycle 1 includes 7 days training period, followed by 28 days treatment (total 35 days). The patients will receive multiple 28-day cycles of continuous Optune treatment. In the absence of treatment related serious adverse events or disease progression, Optune will continue up to 26 cycles.

The patients will be followed up for 30 days after the last application of the Optune device.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Study Start Date : January 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (Optune System)
Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory. All patients will use the study device Optune System (Tumor Treating Fields, TTFields).
Device: Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields)
The Optune, a.k.a. Tumor Treating Fields (TTFields), will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Cycle 1 includes 7 days training period, followed by 28 days treatment (total 35 days). The patients will receive multiple 28-day cycles of continuous Optune treatment. In the absence of treatment related serious adverse events or disease progression, Optune will continue up to 26 cycles.
Other Name: Optune System (NovoTTF-200A System)




Primary Outcome Measures :
  1. The feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. [ Time Frame: days 8 through 35 of cycle 1 ]
    Device Usage Compliance will be reported to assess the feasibility of the device treatment.

  2. The Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. [ Time Frame: 2 years ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.


Secondary Outcome Measures :
  1. The Response Rate [ Time Frame: 2 years ]
    The response rate is calculated according to the bi-dimensional tumor measurement at the end of treatment compared with the baseline measurements.

  2. The Event-Free Survival [ Time Frame: 2 years ]
    The event-free survival is the interval of time between date of initiation of protocol treatment and minimum date of documentation of progressive disease, second malignancy, death due to any cause, or date of last follow-up.

  3. The association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study. [ Time Frame: 2 years ]
    The anti-tumor activity will be classified as complete response, partial response, stable disease, and progressive disease per protocol specified criteria. The compliance in Optune device use will be calculated as the actual hours of Optune device usage per day.

  4. The association between the Optune device usage and the health-related quality of life of children and families undergoing this therapy. [ Time Frame: 2 years ]
    The Quality of Life Scores will be reported at baseline, and with each cycle using PROMIS and Neuro-QoL Stigma, in which the mean score of the general population is 50 and standard deviation is 10.

  5. The association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS. [ Time Frame: 2 years ]
    We will summarize the tumor-type specific ADC value at baseline and at various times on treatment as well as within-patient changes over time. The ADC value of responders will be compared to the ADC value of those with progressive diseases at baseline and over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis: Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory.
  • Patients must have failed standard therapy and at the time of study entry have recurrent, progressive or refractory disease with no known curative options.
  • Disease Status: Patients must have bi-dimensionally measureable disease, defined as at least one lesion that can be accurately measured in at least two planes

    • This disease must be located primarily in the supratentorial region
    • Patients with significant disease that is metastatic outside of the supratentorial region are ineligible
  • Age: Patients must be ≥ 5 but ≤ 21 years of age at the time of enrollment.
  • Prior Therapy: Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  • Myelosuppressive Chemotherapy: Patients must have received last dose of known myelosuppressive chemotherapy >21 days prior to enrollment; >42 days if nitrosurea.
  • Biologic Agent: Biologic agent must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent > 7 days prior to study enrollment.

    - For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.

  • Immunomodulatory treatment: Patient must have received the last dose >21 days prior to enrollment.

    - Monoclonal antibody treatment and agents with known prolonged half-lives: At least three half-lives must have elapsed prior to enrollment.

  • Radiation: Patients must have had their last fraction of:

    • Craniospinal irradiation (>24Gy) > 3 months prior to enrollment
    • Focal irradiation > 42 days prior to enrollment
    • Local palliative irradiation (small port) > 14 days
  • Surgery: Optune device application start date must be at least 4 weeks (28 days) from CNS surgical procedure. Excluding VP shunts, Endoscopic Third Ventriculostomy (ETV) for which treatment could start 10 days post procedure. Non-CNS surgical procedures such as but not limited to central venous catheter insertion at the discretion of treating physician and study chair.
  • Inclusion of Women and Minorities: Both males and females of all races and ethnic groups are eligible for this study.
  • Neurologic Status: Patients with neurological deficits should be stable for a minimum of 1 week prior to enrollment.
  • Performance Status: Karnofsky Performance Scale (KPS for > 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within two weeks of enrollment must be ≥ 60. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Organ Function: Patients must have organ and marrow function as defined below:

Absolute neutrophil count ≥ 1.0 X 109/L; Platelets ≥ 100 X 109/L (transfusion independent); Hemoglobin ≥8g/dl (may receive transfusions); Total bilirubin ≤1.5 times institutional upper limit of normal (ULN); ALT(SGPT) ≤3 times institutional upper limit of normal; AST(SGOT) ≤3 times institutional upper limit of normal; Albumin ≥2 g/dl. Serum creatinine based on age/gender as noted below. Patients that do not meet the criteria below but have a 24 hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 ml/min/1.73 m2 are eligible.

Age Maximum Serum Creatinine (mg/dL)

3 to < 6 years 0.8 (Male) 0.8 (Female); 6 to < 10 years 1 (Male) 1 (Female); 10 to < 13 years 1.2 (Male) 1.2 (Female); 13 to < 16 years 1.5 (Male) 1.4 (Female);

≥ 16 years 1.7 (Male) 1.4 (Female).

  • Head circumference: Patients must have minimum head circumference of 44 cm.
  • Compliance in Optune Device Usage: Patients must be willing to use the Optune device ≥18 hours/day for at least 23 days in a 28-day cycle, and keep head shaved throughout treatment.
  • Pregnancy Status: Female patients of childbearing potential must have a negative serum or urine pregnancy test.
  • Pregnancy Prevention: Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
  • Informed Consent: The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines.
  • Steroids: If patient is on corticosteroids, the dose must be stable or decreasing for at least 5 days prior to enrollment.

Exclusion Criteria:

  • Systemic Illness: Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
  • Other Malignancy: Patients with a history of any other malignancy.
  • Concurrent Therapy: Patients who are receiving any other anticancer or investigational drug therapy are not eligible.
  • Inability to Participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to device usage plan, other study procedures, and study restrictions.
  • Tumor Location: Patients with primarily infra-tentorial or spinal cord tumor are not eligible.
  • Tumor Dissemination: Patients for who clinical suspicion is present of metastatic disease in the CSF or Spine must have MRI of Spine and CSF obtained (Lumbar puncture or through ommaya, EVD or Shunt) with negative cytology. Patients with CSF that is positive for tumor cells or metastatic disease found on MRI are ineligible.
  • Skull Defects: Patients with major skull defects (such as missing bone without replacement) are not eligible.
  • Neurological Disorder: Patients with active implanted electronic devices in the brain or spinal cord such as programmable VP shunts, deep brain stimulators, vagus nerve stimulators, are not allowed.
  • Cardiac Disorder: Patients with pacemaker, defibrillator, or documented significant arrhythmia, are not allowed.
  • Intracranial Objects: Patients with foreign body intracranially, such as bullet fragments, are not allowed, with the exception of VP-shunts (non-programmable) and Ommaya catheters.
  • Allergy: Patients with history of hypersensitivity to conductive hydrogel are not eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033992


Contacts
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Contact: Shujie Han, Ph.D., CCRA 901-595-4877 Shujie.Han@stjude.org
Contact: Stacye Richardson, MSHS, CCRP 901-595-3783 Stacye.Richardson@stjude.org

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90026
Contact: Nathan Robison, MD    323-361-8147    nrobison@chla.usc.edu   
Contact: Ryan Turner    323-361-4276    ryturner@chla.usc.edu   
Principal Investigator: Nathan Robison, MD         
Lucile Packard Children's Hospital at Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Michelle Monje, MD, PhD    650-721-5750    mmonje@stanford.edu   
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010-2970
Contact: Gene Hwang, MD    202-476-5046    ghwang@childrensnational.org   
United States, Illinois
Stewart Goldman Recruiting
Chicago, Illinois, United States, 60611
Contact: Stewart Goldman    312-227-4844    sgoldman@luriechildrens.org   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ira Dunkel, MD    212-639-2153    dunkeli@mskcc.org   
Contact: Melissa Leelou    646-888-5722    leeoloum@mskcc.org   
Principal Investigator: Ira Dunkel, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Maryam Fouladi, MD    513-803-0721    maryam.fouladi@cchmc.org   
Contact: CCHMC Cancer Line    513-636-2799    Cancer@cchmc.org   
United States, Pennsylvania
Children Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Ian Pollack, MD    412-692-5881    Pollaci@chp.edu   
Contact: Sharon DiBridge    412-692-7070    sharon.dibridge@chp.edu   
Principal Investigator: Ian Pollack         
United States, Tennessee
Saint Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105-2794
Contact: Anna Vinitsky, MD    901-595-3300    anna.vinitsky@stjude.org   
Contact: Tabatha Doyle    901-595-2544    tabatha.doyle@stjude.org   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Patricia Baxter, MD    832-824-4681    pabaxter@txch.org   
Contact: Susan Burlingame, CCRP    832-824-1532    sxburlin@txch.org   
Principal Investigator: Patricia Baxter, MD         
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stewart Goldman, MD Ann & Robert H. Lurie Children Hospital of Chicago

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Responsible Party: Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier: NCT03033992     History of Changes
Other Study ID Numbers: PBTC-048
5UM1CA081457 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glioma
Ependymoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue