Clinical Trials / Research Studies

Clinical Trials / Research Studies

PBTC-048: Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma

Why are we doing this research?

PURPOSE:

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:

  • To establish the feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.
  • To describe the Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.

Study Type: Interventional
Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Who can participate?

AGES ELIGIBLE FOR STUDY: 1 year to 90 Years

ELIGIBILITY 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.

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.

Conditions

  • Brain and Spinal Tumor DIPG High Grade Glioma Relapse - Refractory
  • Brain and Spinal Tumor Ependymoma Relapse
  • Adult - Brain and Spinal Tumor DIPG High Grade Glioma Relapse - Refractory
  • Adult - Brain and Spinal Tumor Ependymoma Relapse

Contact

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org