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Adult Brain GlioblastomaPhase 2NCT02348255

NovoTTF-100A With Bevacizumab and Carmustine in Treating Patients With Glioblastoma Multiforme in First Relapse

A Phase 2 study testing Electric Field Therapy, Bevacizumab and Carmustine in people with Adult Brain Glioblastoma and Recurrent Adult Brain Neoplasm, run by University of California, Davis at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies the safety of NovoTTF-100A in combination with bevacizumab and carmustine and to see how well they work in treating patients with glioblastoma multiforme that has returned for the first time. Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
Electric Field Therapy, Bevacizumab and Carmustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jan 2016to Jan 2017
Phase
Phase 2
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
  • Progressive disease after temozolomide and radiation therapy (in "first relapse")
  • At least 28 days since chemotherapy or radiation
  • Karnofsky performance score at least 70%
  • Platelet count >= 130/mm^3
  • Absolute neutrophil count >= 1500/mm^3
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  • Calculated creatinine clearance greater than 45 mg/dl using the Cockcroft-Gault formula
  • Aspartate aminotransferase (AST) < 2 times the upper limit of normal
  • Bilirubin < 1.5 times the upper limit of normal
  • Subjects with child-bearing potential agree to use effective means of contraception

Who cannot join

  • Prior systemically administered nitrosoureas or vascular endothelial growth factor (VEGF) targeted therapy
  • Chemotherapy for glioma other than temozolomide or Gliadel wafers (steroids are allowed)
  • Pregnant or breast feeding
  • Active inflammatory bowel disease
  • Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months
  • Hypertension: systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 100 mm mercury (Hg) despite antihypertensive medications
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  • New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); myocardial infarction or unstable angina within 6 months
  • History of thrombosis
  • Symptomatic peripheral vascular disease, stroke or transient ischemic attack within 6 months
  • Bleeding risks: Required to be on therapeutic anticoagulation (aspirin is allowed), coagulopathy (e.g. hemophilia or von Willebrand's disease); any grade III or greater hemorrhage, major surgical procedure, or significant trauma within 28 days; core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days
  • Activated partial thromboplastin time (APTT) must not exceed 32.5 seconds (normal range 21.8-31.5 seconds); international normalized ratio (INR) must not exceed 1.30 (normal range 0.87-1.18)
  • Serious, non-healing wound, ulcer, or bone fracture
  • Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts), a skull defect (such as missing bone with no replacement), a shunt, or bullet fragments
  • Known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
  • Human immunodeficiency virus (HIV) positive
  • Proteinuria at screening as demonstrated by urine dipstick >= 2+
  • Prior organ transplantation
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel or any other drug whose goal is to inhibit platelet function
  • Unable to give signed informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: A Phase II, Multi-institutional Trial of NOVO-TTF-100A, BCNU and Bevacizumab for GBM in First Relapse

This phase II trial studies the safety of NovoTTF-100A in combination with bevacizumab and carmustine and to see how well they work in treating patients with glioblastoma multiforme that has returned for the first time. NovoTTF-100A, a type of electric field therapy, delivers low intensity, alternating "wave-like" electric fields that may interfere with multiplication of the glioblastoma multiforme cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NovoTTF-100A together with bevacizumab and carmustine may be an effective treatment for glioblastoma multiforme.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Establish the safety of NovoTTF-100A in combination with bevacizumab and BCNU (carmustine) in glioblastoma multiforme (GBM) patients who have relapsed after chemoradiation therapy (first relapse).

II. Determine the 6 month overall survival (OS). III. Determine the 6 month progression free survival (PFS). IV. Evaluate the effect of this therapy regimen on quality-of-life.

OUTLINE:

Patients receive bevacizumab intravenously (IV) over 30-90 minutes every 2 weeks beginning on day -7 for up to 13 doses and carmustine IV over 4 hours every 8 weeks beginning on day 1 for up to 3 doses. Patients also undergo NovoTTF-100A according to standard procedures starting one week before the first dose of carmustine.

After completion of study treatment, patients are followed up for 12 months.

Being tested
Electric Field Therapy, Bevacizumab, Carmustine, Quality-of-Life Assessment
Medical subject headings
Brain Neoplasms

What participants receive

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

  • Electric Field TherapyProcedure or surgery

    Undergo NovoTTF-100A

  • BevacizumabBiological

    Also called Avastin, rhuMab-VEGF

    Given IV

  • CarmustineDrug

    Also called FDA 0345

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02348255
Study groupRoleWhat they receive
Treatment (bevacizumab, carmustine, NovoTTF-100A)ExperimentalPatients receive bevacizumab IV over 30-90 minutes every 2 weeks beginning on day -7 for up to 13 doses and carmustine IV over 4 hours every 8 weeks beginning on day 1 for up to 3 doses. Patients also undergo NovoTTF-100A according to standard procedures starting one week before the first dose of carmustine.
Receives: Procedure: Electric Field Therapy; Biological: Bevacizumab; Drug: Carmustine; Other: Quality-of-Life Assessment

What is being measured

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

  1. Incidence of adverse events, assessed by National Cancer Institute-Common Terminology Criteria 4.0 toxicity criteria

    Toxicity summaries will be provided for all subjects who have received any part of the study treatment. Statistical analysis will include estimates of proportions with each class of toxicity with a 95% confidence interval.

    Measured: Up to 12 months

  2. Progression Free Survival

    Will be estimated using the product-limit method of Kaplan and Meier.

    Measured: Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 6 months

  3. Overall Survival

    Will be estimated using the product-limit method of Kaplan and Meier.

    Measured: Time from first day of treatment to time of death due to any cause, assessed up to 6 months

  4. Quality of life as measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN-20 brain cancer module

    Measured: Up to 6 months

  5. Change in tumor volume using magnetic resonance imaging (MRI)

    Mean change in linear dimension will be evaluated for shrinkage using a paired t-test. If the assumption of normality is violated, a signed rank test will be used. The Response Assessment in Neuro-oncology (RANO) criteria will be part of the MRI evaluation.

    Measured: Baseline to day 168

  6. Change in linear dimension using MRI

    Mean change in linear dimension will be evaluated for shrinkage using a paired t-test. If the assumption of normality is violated, a signed rank test will be used. The RANO criteria will be part of the MRI evaluation.

    Measured: Baseline to day 168

Timeline

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

  1. First posted28 Jan 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Why it stopped: Poor Accrual

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02348255
Sponsor's protocol ID
UCDCC#249
Other IDs
663113, UCDCC#249, P30CA093373, NCI-2014-02628
Status last verified
Jan 2018
First submitted
22 Jan 2015
Last updated
9 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Electric Field Therapy, Bevacizumab and Carmustine in people with Adult Brain Glioblastoma and Recurrent Adult Brain Neoplasm, run by University of California, Davis 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 10 inclusion and 20 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: withdrawn, as of the sponsor's last update on 9 Jan 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of adverse events, assessed by National Cancer Institute-Common Terminology Criteria 4.0 toxicity criteria (time frame: Up to 12 months). The study lists 6 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 NCT02348255.

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 9 Jan 2018.

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