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

Primary Purpose

Anaplastic Oligodendroglioma, Oligoastrocytoma, Oligodendroglioma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wear novoTTF-200A
Quality-of-Life Assessment
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Oligodendroglioma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (medical device)

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma
Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.03

Secondary Outcome Measures

Full Information

First Posted
November 21, 2017
Last Updated
December 8, 2020
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI), NovoCure Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03353896
Brief Title
NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma
Official Title
Pilot Trial of NovoTTF -200A (TTFields) in Patients With Newly Diagnosed High Risk Oligodendrogliomas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient accrual
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 8, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI), NovoCure Ltd.

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24. II. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Oligodendroglioma, Oligoastrocytoma, Oligodendroglioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (medical device)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wear novoTTF-200A
Other Intervention Name(s)
Medical Devices
Intervention Description
Wear novoTTF-200A device
Intervention Type
Procedure
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma
Description
Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.03
Time Frame
Up to 2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Chen, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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