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Trial record 12 of 230 for:    "Anaplastic oligodendroglioma"

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

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ClinicalTrials.gov Identifier: NCT03353896
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NovoCure Ltd.
Information provided by (Responsible Party):
University of Southern California

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 disease Intervention/treatment Phase
Anaplastic Oligodendroglioma Oligoastrocytoma Oligodendroglioma Device: Wear novoTTF-200A Procedure: Quality-of-Life Assessment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 : December 15, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2020


Arm Intervention/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 Name: Medical Devices
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment



Primary Outcome Measures :
  1. Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353896


Contacts
Contact: Sandy Leong, RN 323-442-7532 sandyleo@usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Sandy Leong, RN    323-442-7532    sandyleo@usc.edu   
Principal Investigator: Thomas C. Chen, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
NovoCure Ltd.
Investigators
Principal Investigator: Thomas Chen, MD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03353896     History of Changes
Other Study ID Numbers: 6B-15-1
NCI-2017-02074 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EF-OLIGO-15
6B-15-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Oligodendroglioma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue