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GlioblastomaNCT01954576

NovoTTF Therapy in Treating Patients With Recurrent Glioblastoma Multiforme

A study testing NovoTTF-100A, Quality-of-life assessment and Laboratory biomarker analysis in people with Glioblastoma and Brain Neoplasms, run by University of Florida at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This pilot phase II trial studies how well Novocure's Tumor Treating Electric Fields (NovoTTF) therapy works in treating patients with recurrent glioblastoma multiforme. NovoTTF therapy uses a low intensity electric current to kill tumor cells. NovoTTF therapy may be effective treatment for brain cancer. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Glioblastoma, Brain Neoplasms
What is being tested?
NovoTTF-100A, Quality-of-life assessment and Laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesUnited States
Study dates
10 Oct 2013to 14 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed GBM (WHO grade IV); rare GBM variants (e.g. gliosarcoma, giant cell GBM, small cell GBM, GBM with oligodendroglioma features, GBM with PNET features) are allowed. Patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of GBM is made.
  • Received radiotherapy of at least 45 Gy and temozolomide chemotherapy as initial treatment for GBM.
  • Unequivocal evidence of recurrent or progressive GBM before or after bevacizumab treatment first based on radiographic appearances then confirmed by histologic confirmation through biopsy or resection.
  • Prior treatment with Gliadel wafer is allowed if it has been at least 3 months from placement.
  • There must be an interval of at least 12 weeks from the completion of radiotherapy to start of device treatment. When the interval is less than 12 weeks from the completion of radiotherapy, the histological confirmation of progression must be unequivocal per RANO criteria. The use of PET scan, perfusion imaging, and MRspectroscopy to differentiate between true early progression and pseudoprogression prior to biopsy or resection of probable recurrent tumor is per standard of care.
  • At least 22 years of age.
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  • Karnofsky performance status of at least 60%.
  • Life expectancy of at least 3 months.
  • Planned biopsy or resection of recurrent tumor for therapeutic and/or diagnostic purpose, and with adequate bone marrow, hepatic, cardiac, and renal function to undergo this planned procedure.
  • For patients who have undergone or will undergo stereotactic biopsy of recurrent or progressive tumor, a post-operative MRI is not required, provided that the pre-biopsy MRI is within 21 days of registration. If the preoperative scan is more than 21 days before registration, the scan needs to be repeated. If the steroid dose is increased more than 50% between the date of biopsy and registration, a new baseline MRI is required on a stable or decreasing steroid dosage for at least 3 days even if the previous MRI was within 21 days of registration.
  • For patients who have undergone or will undergo open resection of recurrent or progressive tumor, residual disease following resection is not mandated for eligibility into the study. To best assess the extent of residual disease post-resection, a MRI scan should be done no later than 96 hours in the immediate post-resection period and within 21 days prior to registration. If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated. If the steroid dose is increased more than 50% between the date of imaging and registration, a new baseline MRI is required on a stable or decreasing steroid dosage for at least 3 days.
  • Planned treatment with NovoTTF Therapy alone per FDA-approved indication. NovoTTF Therapy must start within 14 days of registration, but not less than 7 days or more than 21 days from stereotactic biopsy (if applicable) and not less than 21 days or more than 42 days from open resection (if applicable).
  • Availability of tissue from the initial diagnosis and the recurrent tumor that is estimated to be of sufficient quality and quantity for both genomic DNA and total RNA isolation; preferably some of the tissue would be snap frozen for high quality RNA preparation.
  • Because the genetic analyses described in Section 8.0 will be performed under HRPO# 201111001 ("Analysis of Histological, Genomic, Molecular, and Clinical Factors in CNS Cancer: the Neuro-Oncology Group"), for patients enrolling in this trial at WUSM, it is required that WUSM patients must also enroll in HRPO# 201111001. The genetic analyses for UF patients will take place at WUSM under the auspices of this protocol.
  • Recovery from the toxic effects of prior therapy to not more than grade 1 or >3 weeks from prior therapy to registration, whichever is later.
  • Patients must agree to forgo any other treatments, including but not limited to cytotoxic or biologic chemotherapies, that are intended to treat the recurrent GBM while receiving treatment with NovoTTF Therapy.
  • Participants of childbearing age must use effective contraception.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Who cannot join

  • Any other malignancy that required active chemotherapy within the previous 12 months prior to registration and the disease is not currently progressing and/or metastatic. The exception is basal cell or squamous cell carcinoma of the skin, which were treated with local resection only or carcinoma in situ of the cervix.
  • Unable to undergo brain MRI due to medical or personal reasons.
  • Bevacizumab-naïve patients: These patients may not have more than one prior relapse not counting the current relapse being treated by this protocol and must have received at least one prior chemotherapy regimen, which must have included temozolomide.
  • Bevacizumab-refractory patients: These patients may not have more than 2 prior relapses not counting the current relapse being treated by this protocol and must have received multiple chemotherapy regimens, including a temozolomide regimen and a bevacizumab regimen.
  • Currently receiving any other investigational agents that are intended as treatments of recurrent GBM.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or severe heart problems, or psychiatric illness/social situations that would limit compliance with study requirements.
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  • Pregnant or breastfeeding.
  • Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord.
  • Infra-tentorial tumor.
  • History of hypersensitivity to hydrogel.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Florida

    Gainesville, Florida, 32610

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase II Study of the Optune System, Enhanced by Genomic Analysis to Identify the Genetic Signature of Response in the Treatment of Recurrent Glioblastoma Multiforme

This pilot phase II trial studies how well Novocure's Tumor Treating Electric Fields (NovoTTF) therapy works in treating patients with recurrent glioblastoma multiforme. NovoTTF therapy uses a low intensity electric current to kill tumor cells. NovoTTF therapy may be effective treatment for brain cancer.

Being tested
NovoTTF-100A, Quality-of-life assessment, Laboratory biomarker analysis
Keywords
bevacizumab-naïve recurrent GBM, bevacizumab-refractory GBM
Medical subject headings
Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovoTTF-100ADevice

  • Quality-of-life assessmentProcedure or surgery

  • Laboratory biomarker analysisGenetic

Study groups in NCT01954576
Study groupRoleWhat they receive
NovoTTF therapyExperimentalPatients undergo NovoTFF therapy at least 18 hours daily for 6 months (bevacizumab-naive) or 4 months (bevacizumab-refractory). Treatment may continue for up to 2 years in patients experiencing CR, PR, or SD.
Receives: Device: NovoTTF-100A; Procedure: Quality-of-life assessment; Genetic: Laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR (CR + PR + SD) (bevacizumab-naive)

    Response and progression evaluated using Response Assessment in Neuro-Oncology (RANO). Response is evaluated with the use of MRI every 8 weeks. A Fisher's exact test with two-sided 0.05 and 80% power will be used.

    Measured: 6 months

  2. ORR (CR + PR + SD) (bevacizumab-refractory)

    Response and progression evaluated using Response Assessment in Neuro-Oncology (RANO). Response is evaluated with the use of MRI every 8 weeks. A Fisher's exact test with two-sided 0.05 and 80% power will be used.

    Measured: 4 months

Secondary outcomes (4)

  1. Genetic signature of response (CR + PR + SD)

    Genetic analysis will be performed on the primary tumor tissue and tissue at the time of recurrence. Genomic DNA will be extracted from patients' tumor samples and paired blood samples.

    Measured: up to 6 months

  2. Genetic signature of response (CR + PR) and SD

    Genetic analysis will be performed on the primary tumor tissue and tissue at the time of recurrence. Genomic DNA will be extracted from patients' tumor samples and paired blood samples.

    Measured: Up to 6 months

  3. Progression-free survival in bevacizumab-naïve and bevacizumab-refractory glioblastoma patients

    Defined as start of treatment to time of progression or death, whichever occurs first. Will be estimated by Kaplan-Meier curves.

    Measured: Assessed up to 2 years

  4. Quality of Life

    Assessed using the Karnofsky performance status and the mini-mental state examination.

    Measured: Up to 30 days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2013 (estimated)
  2. Study start10 Oct 2013
  3. Primary completion14 May 2021
  4. Study completion14 May 2021

Why it stopped: Poor accrual; Avastin refractory patients not feasible given treatment paradigm in these patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01954576
Sponsor's protocol ID
IRB201500287
Other IDs
09-27-2013, 201306042, OCR14655
Status last verified
Oct 2022
First submitted
24 Sep 2013
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NovoTTF-100A, Quality-of-life assessment and Laboratory biomarker analysis in people with Glioblastoma and Brain Neoplasms, run by University of Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Poor accrual; Avastin refractory patients not feasible given treatment paradigm in these patients.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (CR + PR + SD) (bevacizumab-naive) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.

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