ACTIVE_NOT_RECRUITING

Optune for Children With High-Grade Glioma or Ependymoma, and Optune With Radiation Therapy for Children With DIPG

Conditions

Malignant Glioma Ependymoma Diffuse Intrinsic Pontine Glioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter trial of the Optune device to examine the feasibility and to describe the device-related toxicity in children with supratentorial high grade glioma (HGG) or ependymoma (Stratum 1) and to examine the feasibility and efficacy of concurrent Optune and standard focal radiation therapy (RT) in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum 2).

Official Title

Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma or Ependymoma, and Feasibility and Efficacy Trial of Optune in Conjunction With Radiation Therapy for Children With Newly Diagnosed DIPG

Quick Facts

Study Start:2017-04-04

Study Completion:2031-07-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03033992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Age: at the time of enrollment Stratum 1: ≥ 5 years but ≤ 21 Stratum 2: ≥ 3 years but ≤ 21 * Diagnosis: * Patients with a typical DIPG on MR imaging, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation. * Note: Patients with typical DIPG who undergo a biopsy are eligible provided the tumor is a diffuse glioma WHO Grade II-IV with OR without H3 K27M mutation. * Patients with pontine lesions that do not meet these MR imaging criteria will be eligible if there is histologic confirmation diffuse glioma WHO Grade II-IV with H3 K27M-mutation. * Disease Status: Patients must have bi-dimensionally measurable 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 * This disease must be located primarily in the pons * Prior Therapy: * 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. * Immunomodulatory treatment: Patient must have received the last dose \>21 days prior to enrollment. * Stratum 1: Patients must have had their last fraction of: * Focal irradiation ≥ 14 days prior to enrollment * Local palliative irradiation (small port) ≥ 14 days * Stratum 2: Patients must not have received any radiotherapy prior to enrollment. If clinically indicated, enrolled patients may receive up to 5 fractions of radiotherapy prior to starting Optune therapy. * Surgery: * Inclusion of Women and Minorities: Both males and females of all races and ethnic groups are eligible for this study. * Neurologic Status: * Stratum 1: Patients with neurological deficits should be stable for a minimum of 1 week prior to enrollment. * Stratum 2: Stable neurologic deficits are not an eligibility criterion for Stratum 2. * 16 years 1.7 (Male) 1.4 (Female). * Stratum 2: Patients must have adequate organ and marrow function as defined below: * Head circumference: Patients must have minimum head circumference of 44 cm. * Compliance in Optune Device Usage: * Stratum 1: 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. * Stratum 2: During concurrent Optune therapy and RT, patients must be willing to use the Optune device ≥18 hours/day for at least 40 of the 49 days of the duration of the feasibility period. During subsequent cycles of Optune therapy alone, patients must be willing to use the Optune device ≥18 hours/day for at least 23 days in a 28-day cycle. During concurrent Optune therapy and RT and Optune therapy alone, patients must be willing to keep their 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: * Stratum 2: There are no eligibility requirements for corticosteroid dosing for Stratum 2.	* 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. * Stratum 1 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 eligible. * 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.

Inclusion Criteria

Exclusion Criteria

* Age: at the time of enrollment Stratum 1: ≥ 5 years but ≤ 21 Stratum 2: ≥ 3 years but ≤ 21
* Diagnosis:
* Patients with a typical DIPG on MR imaging, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation.
* Note: Patients with typical DIPG who undergo a biopsy are eligible provided the tumor is a diffuse glioma WHO Grade II-IV with OR without H3 K27M mutation.
* Patients with pontine lesions that do not meet these MR imaging criteria will be eligible if there is histologic confirmation diffuse glioma WHO Grade II-IV with H3 K27M-mutation.
* Disease Status: Patients must have bi-dimensionally measurable 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
* This disease must be located primarily in the pons
* Prior Therapy:
* 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.
* Immunomodulatory treatment: Patient must have received the last dose \>21 days prior to enrollment.
* Stratum 1: Patients must have had their last fraction of:
* Focal irradiation ≥ 14 days prior to enrollment
* Local palliative irradiation (small port) ≥ 14 days
* Stratum 2: Patients must not have received any radiotherapy prior to enrollment. If clinically indicated, enrolled patients may receive up to 5 fractions of radiotherapy prior to starting Optune therapy.
* Surgery:
* Inclusion of Women and Minorities: Both males and females of all races and ethnic groups are eligible for this study.
* Neurologic Status:
* Stratum 1: Patients with neurological deficits should be stable for a minimum of 1 week prior to enrollment.
* Stratum 2: Stable neurologic deficits are not an eligibility criterion for Stratum 2.
* 16 years 1.7 (Male) 1.4 (Female).
* Stratum 2: Patients must have adequate organ and marrow function as defined below:
* Head circumference: Patients must have minimum head circumference of 44 cm.
* Compliance in Optune Device Usage:
* Stratum 1: 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.
* Stratum 2: During concurrent Optune therapy and RT, patients must be willing to use the Optune device ≥18 hours/day for at least 40 of the 49 days of the duration of the feasibility period. During subsequent cycles of Optune therapy alone, patients must be willing to use the Optune device ≥18 hours/day for at least 23 days in a 28-day cycle. During concurrent Optune therapy and RT and Optune therapy alone, patients must be willing to keep their 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:
* Stratum 2: There are no eligibility requirements for corticosteroid dosing for Stratum 2.

* 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.
* Stratum 1 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 eligible.
* 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.

Contacts and Locations

Principal Investigator

Stewart Goldman, MD

PRINCIPAL_INVESTIGATOR

Phoenix Children's Hospital

Study Locations (Sites)

Phoenix Children's Hospital

Phoenix, Arizona, 85016

United States

Children's Hospital Los Angeles

Los Angeles, California, 90026

United States

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, 94304

United States

Children's Hospital of Colorado

Aurora, Colorado, 80045

United States

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970

United States

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Pediatric Brain Tumor Consortium

Stewart Goldman, MD, PRINCIPAL_INVESTIGATOR, Phoenix Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-04-04

Study Completion Date2031-07-21

Study Record Updates

Study Start Date2017-04-04

Study Completion Date2031-07-21

Terms related to this study

Additional Relevant MeSH Terms

Malignant Glioma
Ependymoma
Diffuse Intrinsic Pontine Glioma