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A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)

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ClinicalTrials.gov Identifier: NCT02343549
Recruitment Status : Suspended (accrual temporarily suspended during COVID-19 pandemic)
First Posted : January 22, 2015
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Ashley Love Sumrall, Atrium Health

Study Description
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Brief Summary:
All patients will complete best standard of care radiation, temozolomide and bevacizumab (6 weeks). Within two weeks of completion of this initial treatment period, study patients will be fitted with the NovoTTF-100A System and treated continuously. They will be treated with TTFields for 12 months for an average of 18 hours per day. The patient may elect to take a treatment break for a total of 3 days per month, for each month and still be in compliance. This will consist of wearing four electrically insulated electrode arrays on the head. The patients will also continue with maintenance temozolomide/ bevacizumab.

Condition or disease Intervention/treatment Phase
Cancer of Brain and Nervous System Device: bevacizumab, NovoTTF100A, temozolomide Phase 2

Detailed Description:
This study will be carried out in two stages. The first stage will enroll a cohort of 22 patients. The FDA will review safety data of the first 15 patients during enrollment of the first cohort. Enrollment and interim analysis of the first cohort of patients will be completed within 15 months of study commencement. Upon FDA approval and favorable interim analysis followed by subsequent protocol/consent amendment (as applicable), the second stage will enroll a cohort of 24 patients and will be completed within 15 months of stage 2 commencement. The overall duration of the study is expected to be no longer than 30 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)
Study Start Date : January 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
All Patients
 Device: bevacizumab, NovoTTF100A, temozolomide


Outcome Measures
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Primary Outcome Measures :
  1. Survival at 12 months [ Time Frame: 12 months on study ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 22 years of age
  • Have undergone a brain biopsy via stereotactic or open technique
  • Pathological evidence of GBM using WHO classification criteria
  • Planned 6 weeks of concurrent chemoradiotherapy post-biopsy concomitant with temozolomide (45-70Gy)
  • Karnofsky scale greater than or equal to 70
  • Life expectancy at least 3 months
  • Baseline hemoglobin of > 8.0 gm/dL (with or without transfusion)
  • Adequate coagulation defined as PT and INR < 1.5 times the upper limit of normal
  • Signed informed consent
  • Able to start bevacizumab at least 2 weeks but no more than 4 weeks from date of biopsy
  • Able to tolerate MRI of brain and have measurable disease.
  • Participants of childbearing age must use effective contraception for at least 6 months following completion of treatment.

Exclusion Criteria

  • Enrolled in another clinical treatment trial
  • Pregnant or Breast-feeding
  • Any other malignancy aside from localized basal cell or squamous cell carcinoma of the skin
  • Significant co-morbidities at baseline which would prevent maintenance temozolomide
  • Thrombocytopenia (platelet count < 100 x 103 )
  • Neutropenia (absolute neutrophil count < 1.5 x 103 )
  • CTC grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting)
  • Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
  • Total bilirubin> 2 times the upper limit of normal
  • Significant renal impairment (serum creatinine> 1.7 mg/dL)
  • Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
  • Infra-tentorial tumor
  • Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness)
  • History of hypersensitivity reaction to temozolomide or a history of hypersensitivity to DTIC or hydrogel
  • Inability to adequately cover treatment area with TTFields (Tumor Treating Fields)
  • Inability to wear NovoTTF-100A System for an average of 18 hours per 24 hours
  • Currently taking cytotoxic medications, non-steroidal ant-inflammatory drugs (NSAIDS), or enzyme inducing anticonvulsants.
  • Currently taking anticoagulants or blood-thinners (Coumadin)
  • Subjects meeting any of the following bevacizumab-specific contraindications are ineligible for study entry:
  • Inadequately controlled hypertension (defined as systolic blood pressure greater than or equal to 150 and/or diastolic blood pressure > 100 mmHg)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrollment
  • History of hemoptysis (greater than or equal to a half teaspoon of bright red blood per episode) within 1 month prior to study enrollment
  • Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure or significant traumatic injury within 28 days prior to 1st bevacizumab infusion or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • History of abdominal fistula, gastrointestinal perforation within 6 months prior to study enrollment
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Proteinuria at screening as demonstrated by either urine protein: creatinine (UPC) ratio greater than or equal to 1.0 at screening OR urine dipstick for proteinuria greater than or equal to 2 or more (patients discovered to have greater than or equal to 2 or greater proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate less than or equal to 1g of protein in 24 hours to be eligible).
  • Known hypersensitivity to any component of bevacizumab
Contacts and Locations
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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): NCT02343549


Locations
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United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Ashley Love Sumrall
NovoCure Ltd.
Investigators
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Principal Investigator: Ashley Sumrall, MD Atrium Health
More Information
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Responsible Party: Ashley Love Sumrall, Section Chief, Neuro-Oncology, Atrium Health
ClinicalTrials.gov Identifier: NCT02343549    
Other Study ID Numbers: LCI-NEU-NOV-001
00010270
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Bevacizumab
Temozolomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action