Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033992
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : February 15, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pediatric Brain Tumor Consortium

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date February 15, 2021
Actual Study Start Date  ICMJE April 4, 2017
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Official Title  ICMJE Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Glioma
  • Ependymoma
Intervention  ICMJE 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)
Study Arms  ICMJE 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).
Intervention: Device: Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stacye Richardson, MSHS 901-595-3783 stacye.richardson@stjude.org
Contact: Stacye Richardson, MSHS, CCRP 901-595-3783 Stacye.Richardson@stjude.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033992
Other Study ID Numbers  ICMJE PBTC-048
5UM1CA081457 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pediatric Brain Tumor Consortium
Study Sponsor  ICMJE Pediatric Brain Tumor Consortium
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Stewart Goldman, MD Ann & Robert H. Lurie Children Hospital of Chicago
PRS Account Pediatric Brain Tumor Consortium
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP