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Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

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ClinicalTrials.gov Identifier: NCT03705351
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Providence Health & Services Brain & Spine Institute
University of California, San Francisco
NovoCure Ltd.
Information provided by (Responsible Party):
Providence Health & Services

Brief Summary:
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

Condition or disease Intervention/treatment Phase
Glioblastoma Cancer of Brain Glioblastoma Multiforme Brain Tumor Device: Tumor Treating Fields Drug: Temozolomide Radiation: Radiation Therapy Phase 1

Detailed Description:

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months.

Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Sequential Assignment
Intervention Model Description: The study is an open-label pilot study. Following surgery, eligible patients will start tumor treating fields therapy with the Optune device less than 2 weeks prior to radiation and temozolomide given at a dose and schedule conforming to routine treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Patients will receive trimodal therapy consisting of tumor treating fields therapy with the Optune device concurrent with temozolomide and radiation therapy.
Device: Tumor Treating Fields
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.
Other Names:
  • Optune
  • Novocure

Drug: Temozolomide
Patients will be given temozolomide according to routine treatment dosing and schedule.
Other Name: Temodar

Radiation: Radiation Therapy
Patients will be given radiation therapy according to routine treatment dosing and schedule.




Primary Outcome Measures :
  1. Rate of treatment-related adverse events associated with trimodal therapy [ Time Frame: 15 weeks (8 weeks after completion of trimodal therapy) ]
    Number of patients who experienced a treatment-related adverse event

  2. Severity of treatment-related adverse events associated with trimodal therapy [ Time Frame: 15 weeks (8 weeks after completion of trimodal therapy) ]
    Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)


Secondary Outcome Measures :
  1. Progression-free survival at 6 months and 24 months [ Time Frame: 24 months ]
    Number of patients who are progression free at 6 months and 24 months

  2. Overall Survival Rate [ Time Frame: 24 months ]
    Number of patients alive at 24 months



Information from the National Library of Medicine

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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:

  1. GBM or Gliosarcoma by histology
  2. O6-methylguanine-DNA methyltransferase (MGMT) methylation status and isocitrate dehydrogenase (IDH) mutation status must be assessed at the study site or patient's referral center. MGMT status will be used for stratification purposes but will not exclude patients from this study if they are either methylated, unmethylated, or indeterminate, or in process at the time of enrollment. Similarly, subjects with tumors that are IDH mutated or wild type are both eligible.
  3. Supratentorial location
  4. Maximum safe resection (including patients who can only safely be biopsied)
  5. 22 years of age or older
  6. Estimated survival of at least 12 weeks
  7. Karnofsky Performance Status (KPS) 70% or greater at time of entry to study
  8. Stable or decreasing steroid dose tapered down to 8mg or less of dexamethasone per day (or bioequivalent of other corticosteroid) within 1 week after first use of TTField therapy.
  9. Willing and capable of providing written informed consent
  10. Willingness to comply with all procedures, including visits or evaluations, imaging, laboratory tests and rescue measures
  11. Acceptable method of birth control (see appendix)
  12. Have had a contrast-enhanced MRI within 72 hours after tumor resection procedure
  13. The following time periods must have elapsed prior to study enrollment:

A) 3-4 weeks (21-28 days) from time of definitive surgery or 2-4 weeks (14-28 days) from the time of biopsy for those who were only able to safely have a biopsy and not full resection B) Radiation therapy should be started by 3-5 weeks (21-35 days) from surgery or by 2-5 weeks (14-35 days) from time of biopsy and within 2 weeks (14 days) of starting TTField therapy

Exclusion Criteria:

  1. Craniotomy or stereotactic biopsy wound dehiscence or infection
  2. Acquired immune deficiency (HIV+) (testing not required)
  3. Presence of skull defects (bullets, metal fragments, missing bone)
  4. Patients with implanted electronic medical devices (including but not limited to: pacemaker, vagal nerve stimulator, or pain stimulator)
  5. Prior invasive malignancy, unless disease free for 3 or more years
  6. Recurrent malignant gliomas or higher grade gliomas transformed from previous low grade (II) glioma
  7. Patients with any current Primary brain stem or spinal cord tumor
  8. Prior use of temozolomide
  9. Prior treatment with Avastin
  10. Individuals requiring >8mg of dexamethasone per day within 7 days prior to Day 1 (high dose steroid taper following craniotomy with >8mg of dexamethasone is allowed during the screening period, but subjects must taper down to 8mg or less of dexamethasone (or bioequivalent) within 7 days prior to enrollment into the study).
  11. Clinically significant lab abnormalities at baseline showing bone marrow, hepatic, and renal dysfunction:

    • Thrombocytopenia (platelet count < 100 x 103/μL)
    • Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
    • Common toxicity criteria (CTC) grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
    • Significant liver function impairment - Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3 times the upper limit of normal
    • Total bilirubin > upper limit of normal
    • Significant renal impairment (serum creatinine > 1.7 mg/dL)
  12. Inability to swallow pills
  13. Clinically significant or unstable comorbid medical condition (for example, active or uncontrolled infection requiring systemic therapy, including known HIV or hepatitis B or C virus; other active cancer within the prior 3 years with the exception of basal cell carcinoma, cervical carcinoma in situ, or melanoma in situ)
  14. Known current alcohol or drug abuse, per investigator discretion. Prior history of substance abuse is permissible if subject has been sober for the past 3 years.
  15. Any clinically significant psychiatric condition that would prohibit understanding or rendering of informed consent, or prohibit successful performance of study procedures
  16. Patients with an allergy to or an inability to have gadolinium contrast dye administered with MRI are not eligible.
  17. Patients with aneurysm clips or implanted metal objects in the brain are not eligible.
  18. Patients with significant skin breakdown be excluded from enrolling

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): NCT03705351


Contacts
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Contact: Tiffany Gervasi-Follmar 503.216.1023 Tiffany.Gervasi@providence.org

Locations
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United States, Oregon
Providence St. Vincent Medical Center Not yet recruiting
Portland, Oregon, United States, 97225
Contact: Tiffany Gervasi-Follmar    503-216-1023    tiffany.gervasi@providence.org   
Sponsors and Collaborators
Providence Health & Services
Providence Health & Services Brain & Spine Institute
University of California, San Francisco
NovoCure Ltd.
Investigators
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Principal Investigator: Ricky Chen, MD Providence Health and Services

Additional Information:
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT03705351     History of Changes
Other Study ID Numbers: UNITYGBM01
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
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

Keywords provided by Providence Health & Services:
temozolomide
tumor treating fields
optune
novocure
glioblastoma
brain tumor

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
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents