Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

Last updated: August 2, 2023
Sponsor: Providence Health & Services
Overall Status: Terminated

Phase

1

Condition

Astrocytoma

Memory Loss

Brain Tumor

Treatment

Tumor Treating Fields

Temozolomide

Radiation Therapy

Clinical Study ID

NCT03705351
UNITYGBM01
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. GBM or Gliosarcoma by histology
  2. MGMT methylation status and IDH mutation status must be assessed at the study site orpatient's referral center. MGMT status will be used for stratification purposes butwill not exclude patients from this study if they are either methylated, unmethylated,or indeterminate, or in process at the time of enrollment. Similarly, subjects withtumors 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. KPS 70% or greater at time of entry to study
  8. Patient provided written informed consent, or provided by a legally authorizedrepresentative
  9. Willingness to comply with all procedures, including visits or evaluations, imaging,laboratory tests and rescue measures
  10. Acceptable method of birth control (see appendix)
  11. Have had a contrast-enhanced brain MRI after tumor resection procedure. If biopsyalone performed, cranial CT may be used in place of MRI, only if the patient had apreoperative MRI scan within 14 days of the biopsy.
  12. The following time period must have elapsed prior to study enrollment: 3-6 weeks (21-42 days) from time of definitive surgery or 2-4 weeks (14-28 days) from the timeof biopsy, for those who were only able to safely have a biopsy and not fullresection.

Exclusion

Exclusion Criteria:

  1. Craniotomy or stereotactic biopsy wound dehiscence or infection
  2. Known by history to be HIV positive or to have an AIDS-related illness, activeHepatitis B, or active Hepatitis C (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, with the exceptionof basal cell carcinoma, cervical carcinoma in situ, or melanoma in situ
  6. Recurrent malignant gliomas or higher grade gliomas transformed from previous lowgrade (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 (highdose steroid taper following craniotomy with >8mg of dexamethasone is allowed duringthe screening period, but subjects must taper down to 8mg or less of dexamethasone (orbioequivalent) within 7 days prior to Day 1).
  11. Clinically significant lab abnormalities at screening showing bone marrow, hepatic,and renal dysfunction:
  • Thrombocytopenia (platelet count < 100 x 103/μL)
  • Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
  • Significant liver function impairment - AST or ALT > 3 times the upper limit ofnormal
  • Total bilirubin > upper limit of normal
  • Significant renal impairment (serum creatinine > 1.7 mg/dL)
  1. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting) atscreening
  2. Inability to swallow pills
  3. Clinically significant or unstable comorbid medical condition, per investigatordiscretion (for example, active or uncontrolled infection requiring systemic therapy,including known HIV or hepatitis B or C virus)
  4. Known current alcohol or drug abuse, per investigator discretion. Prior history ofsubstance abuse is permissible if subject has been sober for the past 3 years.
  5. Any clinically significant psychiatric condition that would prohibit patientwillingness or ability to successfully complete study procedures, per investigatordiscretion
  6. Patients with an allergy to or an inability to have gadolinium contrast dyeadministered with MRI
  7. Patients with aneurysm clips or implanted metal objects in the brain
  8. Patients with significant skin breakdown on the scalp
  9. Patients who cannot receive standard of care radiation therapy and can only receivehypofractionated radiation due to age and poor performance status , per investigatordiscretion

Study Design

Total Participants: 7
Treatment Group(s): 3
Primary Treatment: Tumor Treating Fields
Phase: 1
Study Start date:
December 02, 2019
Estimated Completion Date:
February 24, 2022

Study 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.

Connect with a study center

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Site Not Available

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