NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma

Sponsor
University of Southern California (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03353896
Collaborator
National Cancer Institute (NCI) (NIH), NovoCure Ltd. (Industry)
0
Enrollment
1
Location
1
Arm
35.8
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot clinical trial studies the side effects of NovoTTF-200A device in treating patients with newly diagnosed high risk oligodendroglioma. NovoTTF-200A device is a portable battery operated device which produces tumor treating (TT)Fields in the body by means of surface electrodes placed on the skin. TTFields are very low intensity, intermediate frequency electric fields that may slow the growth of tumor cells in patients with high risk oligodendroglioma.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Wear novoTTF-200A
  • Procedure: Quality-of-Life Assessment
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To describe the safety and tolerability of the TTFields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment.
SECONDARY OBJECTIVES:
  1. To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24.

  2. To estimate the progression free survival time. III. To assess quality of life. IV. To assess whether or not there is a correlation between genomics and the efficacy of the TTFields treatment.

OUTLINE:

Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours daily (QD). Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 months and then monthly thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Trial of NovoTTF -200A (TTFields) in Patients With Newly Diagnosed High Risk Oligodendrogliomas
Actual Study Start Date :
Dec 15, 2017
Actual Primary Completion Date :
Dec 8, 2020
Actual Study Completion Date :
Dec 8, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment (medical device)

Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours QD. Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.

Device: Wear novoTTF-200A
Wear novoTTF-200A device
Other Names:
  • Medical Devices
  • Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma [Up to 2 months after treatment]

      Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.03

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Newly diagnosed oligodendroglioma (oligo) (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification

    • Surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiation

    • Historical pathological tissue evidence of high risk oligo (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification

    • 1p and 19q deletion status known

    • IDH 1 & 2 mutations status known

    • MGMT status known

    • Karnofsky equal or greater than 70

    • Life expectancy at least 3 months

    • Participants of childbearing age must use effective contraception

    • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or

    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

    • Ability to understand and the willingness to sign a written informed consent

    Exclusion Criteria:
    • Actively participating in another clinical treatment trial

    • Tumor progression after radiation

    • Pregnant

    • Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain

    • Documented clinically significant cardiac arrhythmias

    • Infra-tentorial tumor

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1USC / Norris Comprehensive Cancer CenterLos AngelesCaliforniaUnited States90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)
    • NovoCure Ltd.

    Investigators

    • Principal Investigator: Thomas Chen, MD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03353896
    Other Study ID Numbers:
    • 6B-15-1
    • NCI-2017-02074
    • EF-OLIGO-15
    • 6B-15-1
    • P30CA014089
    First Posted:
    Nov 27, 2017
    Last Update Posted:
    Dec 10, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 10, 2020