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Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma

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ClinicalTrials.gov Identifier: NCT03477110
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information
First Submitted Date  ICMJE March 19, 2018
First Posted Date  ICMJE March 26, 2018
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE May 4, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
NovoTTF-200A device discontinuation rate due to skin toxicity [ Time Frame: Up to 30 days after finishing chemoradiation treatment ]
Discontinuation events are defined as the discontinuation of NovoTTF-200A device for > 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
NovoTTF-100A device discontinuation rate due to skin toxicity [ Time Frame: Up to 30 days after finishing chemoradiation treatment ]
Discontinuation events are defined as the discontinuation of NovoTTF-100A device for > 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.
Change History Complete list of historical versions of study NCT03477110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
  • Progression-free survival [ Time Frame: From enrollment up to 1 year ]
    Will be evaluated using the Kaplan-Meier method.
  • Overall survival [ Time Frame: From enrollment up to 1 year ]
    Will be evaluated using the Kaplan-Meier method.
  • Event-free survival [ Time Frame: From enrollment up to 1 year ]
    Will be evaluated using the Kaplan-Meier method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
Official Title  ICMJE SPARE—Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study
Brief Summary This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.
Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the safety and toxicity of combination chemoradiotherapy with NovoTTF-200A device (Optune) treatment in newly diagnosed glioblastoma.

SECONDARY OBJECTIVES:

I. To determine the median progression-free survival of patients with newly diagnosed glioblastoma treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.

II. To evaluate the median overall survival, 1-year overall survival, and event-free survival.

III. Collect tumor O(6)-Methylguanine-DNA-methyltransferase (MGMT) methylation status and isocitrate dehydrogenase (IDH) mutation status.

IV. To evaluate the level of circulating tumor deoxyribonucleic acid (DNA) in glioblastoma patient serum during treatment.

V. To evaluate the quality of life of patients treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: Temozolomide
    Given PO
    Other Names:
    • 362856
    • Temcad
    • Temodal
    • Methazolastone
    • Temodar
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other Names:
    • Cancer Radiotherapy
    • Irradiate
    • RT
  • Device: NovoTTF-200A Device
    Undergo tumor treatment fields therapy using NovoTTF-200A device
    Other Name: Optune
  • Procedure: Tumor Treating Fields Therapy
    Undergo tumor treatment fields therapy using NovoTTF-200A device
    Other Name: Alternating Electric Field Therapy
Study Arms  ICMJE Experimental: Treatment (temozolomide, radiation, NovoTTF-200A device)
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: Temozolomide
  • Radiation: Radiation Therapy
  • Device: NovoTTF-200A Device
  • Procedure: Tumor Treating Fields Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2018)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with pathology confirmed newly diagnosed World Health Organization (WHO) grade IV glioma
  • Karnofsky performance status (KPS) ≥ 60
  • Patients must have recovered from the effects of surgery per treating physician's judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed prior to the day of protocol treatment
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3
  • Platelets ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 9.0 g/dl
  • Creatinine clearance > 30 mL/min
  • Bilirubin < 2.0 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit of normal range
  • Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose of temozolomide
  • Is able to have magnetic resonance imaging (MRI) with contrast of the brain
  • All subjects must be able to comprehend and sign a written informed consent document. If the subject can comprehend the informed consent but is unable to sign, a LAR may sign the written informed consent document.

Exclusion Criteria:

  • Infratentorial disease (defined as glioblastoma [GBM] derived from cerebellum or brainstem)
  • Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
  • A skull defect (such as, missing bone with no replacement)
  • Women of childbearing potential who are pregnant or breastfeeding
  • Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema)
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator
  • Prior radiation treatment to the brain
  • Prior treatment with temozolomide
  • Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
  • Known active collagen vascular disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wenyin Shi, MD 215-955-6702 wenyin.shi@jefferson.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03477110
Other Study ID Numbers  ICMJE 17P.346
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE NovoCure Ltd.
Investigators  ICMJE
Principal Investigator: Wenyin Shi, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP