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Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma

Primary Purpose

Brain Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optune (NovoTTF-100A)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Cancer focused on measuring intracranial supratentorial meningioma, Atypical and Anaplastic Meningioma, Optune (NovoTTF-100A), 13-067

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proven recurrent WHO grade II (atypical) or grade III (anaplastic) intracranial supratentorial meningioma. MSKCC central review of histology is not required.
  • Unequivocal evidence for tumor progression by MRI with and without contrast and with perfusion (or CT scan is MRI with contraindicated). The scan must be performed within 14 days of registration.
  • Patients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imaging
  • Patients with recent resection for recurrent disease must have recovered from the effects of surgery and should not start treatment for at least 28 days after surgery.
  • Patients must have measurable disease, defined as at least 1cm x 1 cm of contrast enhancing disease.
  • Patients must have received prior radiotherapy for meningioma. Patients may have received standard external beam radiation, interstitial brachytherapy, or radiosurgery in any combination. An interval of > 4 weeks (28 days) must have elapsed from the completion of radiotherapy to study entry and there must be subsequent evidence of tumor progression. Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR-perfusion, MR-spectroscopy, or surgical documentation of disease. If there is any question, investigators should discuss with the MSKCC PI.
  • Prior therapy: there is no limit on the number of prior surgeries, radiation therapy treatments, radiosurgery treatments, or chemotherapy.
  • All patients must be able to provide informed consent indicating that they are aware of the investigational nature of the study. Patients must provide an authorization for the release of their protected health information.
  • Age > or = to 18 years old
  • Karnofsky performance status > or = to 60%
  • 4 weeks (28 days) from any radiation treatment, stereotactic radiosurgery, conventional surgery, or chemotherapy.
  • Life expectancy at least 3 months
  • Patients with NF (Neurofibromatosis) are eligible, and may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months.

Exclusion Criteria:

  • Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for the disease for a minimum of 3 years).
  • Concomitant use of any other investigational drugs.
  • Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials (i.e. Quality of life) are allowed.
  • Pregnancy or breast feeding. Patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to effective contraception. Female patients of child bearing potential (ages 11-55) must have a negative B-HCG pregnancy test documented within 14 days prior to registration.
  • Implanted medical device such as a pacemaker, defibrillator, deep brain stimulator, or vagus nerve stimulator, or documented significant arrhythmia at the discretion of the investigator.
  • Evidence of increased intracranial pressure (midline shift >5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness).
  • Infratentorial meningioma (patients may have infratentorial meningioma if there is concurrent growing supratentorial meningioma that serves as the target lesion)
  • Coagulopathy (as evidenced by PT or APTT >1.5 times upper limit of normal in patients not undergoing anticoagulation)
  • Thrombocytopenia (platelet count <100x10^3/uL) Neutropenia (absolute neutrophil count <1x10^3/uL)
  • Severe acute infection
  • Skull defect with missing bone
  • Ventricular shunt/catheter
  • Presence of a foreign body intracranially such as a bullet fragment

Sites / Locations

  • Cedars-Sinai Medical Center
  • University of Colorado
  • University of Miami
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center at Commack
  • Memorial Sloan Kettering West Harrison
  • Memorial Sloan Kettering Cancer Center
  • Columbia University
  • University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optune (NovoTTF-100A)

Arm Description

The treatment plan is to have patients use the Optune device in monotherapy for ≥ 18 hours per day as per the treatment standard established from prior studies. A medical professional will see each patient at least once per month while on the device for toxicity assessment, compliance evaluation via downloading of the log-file on the device by the Novocure technician (which involves the technician simply attaching the device to a computer via USB where software reads how many hours per day on each day the device was used), and physical examination. Extent of disease evaluations will occur at baseline, 8 weeks, and then every 8 weeks thereafter. These evaluations will include MRI of the brain with and without contrast and perfusion (or CT head if a patient cannot undergo MRI).

Outcomes

Primary Outcome Measures

progression-free survival rate
From the treatment start date to the date of the first observation of progressive disease (including clinical progression) or death due to any cause. Patients not known to be progression-free at 6 months will be considered treatment failures.

Secondary Outcome Measures

overall survival
From the treatment start date to date of death of any cause.
safety and tolerability
graded according to most up-to-date CTCAE version

Full Information

First Posted
July 1, 2013
Last Updated
June 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NovoCure Ltd., Columbia University, University of Cincinnati, University of Colorado, Denver, University of Miami, Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01892397
Brief Title
Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
Official Title
Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2013 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NovoCure Ltd., Columbia University, University of Cincinnati, University of Colorado, Denver, University of Miami, Cedars-Sinai Medical Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to find out what effects, good or bad, the Optune device has on the patient and meningioma. This study is being done because currently there are no proven effective medical treatments for a progressive meningioma that has failed surgery and/or radiation. The study uses an experimental device called Optune. Optune is "experimental" because it has not been approved by the U.S. Food and Drug Administration (FDA) for this type of tumor, although it has been approved for a different type of brain tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer
Keywords
intracranial supratentorial meningioma, Atypical and Anaplastic Meningioma, Optune (NovoTTF-100A), 13-067

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Optune (NovoTTF-100A)
Arm Type
Experimental
Arm Description
The treatment plan is to have patients use the Optune device in monotherapy for ≥ 18 hours per day as per the treatment standard established from prior studies. A medical professional will see each patient at least once per month while on the device for toxicity assessment, compliance evaluation via downloading of the log-file on the device by the Novocure technician (which involves the technician simply attaching the device to a computer via USB where software reads how many hours per day on each day the device was used), and physical examination. Extent of disease evaluations will occur at baseline, 8 weeks, and then every 8 weeks thereafter. These evaluations will include MRI of the brain with and without contrast and perfusion (or CT head if a patient cannot undergo MRI).
Intervention Type
Device
Intervention Name(s)
Optune (NovoTTF-100A)
Primary Outcome Measure Information:
Title
progression-free survival rate
Description
From the treatment start date to the date of the first observation of progressive disease (including clinical progression) or death due to any cause. Patients not known to be progression-free at 6 months will be considered treatment failures.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Description
From the treatment start date to date of death of any cause.
Time Frame
2 year
Title
safety and tolerability
Description
graded according to most up-to-date CTCAE version
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven recurrent WHO grade II (atypical) or grade III (anaplastic) intracranial supratentorial meningioma. MSKCC central review of histology is not required. Unequivocal evidence for tumor progression by MRI with and without contrast and with perfusion (or CT scan is MRI with contraindicated). The scan must be performed within 14 days of registration. Patients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imaging Patients with recent resection for recurrent disease must have recovered from the effects of surgery and should not start treatment for at least 28 days after surgery. Patients must have measurable disease, defined as at least 1cm x 1 cm of contrast enhancing disease. Patients must have received prior radiotherapy for meningioma. Patients may have received standard external beam radiation, interstitial brachytherapy, or radiosurgery in any combination. An interval of > 4 weeks (28 days) must have elapsed from the completion of radiotherapy to study entry and there must be subsequent evidence of tumor progression. Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR-perfusion, MR-spectroscopy, or surgical documentation of disease. If there is any question, investigators should discuss with the MSKCC PI. Prior therapy: there is no limit on the number of prior surgeries, radiation therapy treatments, radiosurgery treatments, or chemotherapy. All patients must be able to provide informed consent indicating that they are aware of the investigational nature of the study. Patients must provide an authorization for the release of their protected health information. Age > or = to 18 years old Karnofsky performance status > or = to 60% 4 weeks (28 days) from any radiation treatment, stereotactic radiosurgery, conventional surgery, or chemotherapy. Life expectancy at least 3 months Patients with NF (Neurofibromatosis) are eligible, and may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months. Exclusion Criteria: Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for the disease for a minimum of 3 years). Concomitant use of any other investigational drugs. Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials (i.e. Quality of life) are allowed. Pregnancy or breast feeding. Patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to effective contraception. Female patients of child bearing potential (ages 11-55) must have a negative B-HCG pregnancy test documented within 14 days prior to registration. Implanted medical device such as a pacemaker, defibrillator, deep brain stimulator, or vagus nerve stimulator, or documented significant arrhythmia at the discretion of the investigator. Evidence of increased intracranial pressure (midline shift >5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness). Infratentorial meningioma (patients may have infratentorial meningioma if there is concurrent growing supratentorial meningioma that serves as the target lesion) Coagulopathy (as evidenced by PT or APTT >1.5 times upper limit of normal in patients not undergoing anticoagulation) Thrombocytopenia (platelet count <100x10^3/uL) Neutropenia (absolute neutrophil count <1x10^3/uL) Severe acute infection Skull defect with missing bone Ventricular shunt/catheter Presence of a foreign body intracranially such as a bullet fragment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kaley, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma

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