Summary

for people ages 22 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Nicholas Butowski

Description

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.

Official Title

Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)

Details

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.

Keywords

Glioblastoma Cancer of Brain Glioblastoma Multiforme Brain Tumor temozolomide tumor treating fields optune novocure Brain Neoplasms Radiation Therapy

Eligibility

You can join if…

Open to people ages 22 years and up

  1. GBM or Gliosarcoma by histology
  2. MGMT methylation status and 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. KPS 70% or greater at time of entry to study
  8. Willing and capable of providing written informed consent
  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 MRI within 72 hours after tumor resection procedure
  12. . The following time period must have elapsed prior to study enrollment: 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

You CAN'T join if...

  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:
  12. Thrombocytopenia (platelet count < 100 x 103/μL)
  13. Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
  14. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
  15. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
  16. Total bilirubin > upper limit of normal
  17. Significant renal impairment (serum creatinine > 1.7 mg/dL)
  18. . Inability to swallow pills
  19. . 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)
  20. . 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.
  21. . Any clinically significant psychiatric condition that would prohibit understanding or rendering of informed consent, or prohibit successful performance of study procedures
  22. . Patients with an allergy to or an inability to have gadolinium contrast dye administered with MRI are not eligible.
  23. . Patients with aneurysm clips or implanted metal objects in the brain are not eligible.
  24. . Patients with significant skin breakdown be excluded from enrolling

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Providence St. Vincent Medical Center not yet accepting patients
    Portland Oregon 97225 United States

Lead Scientist

  • Nicholas Butowski
    Professor, Neurological Surgery. Authored (or co-authored) 97 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Providence Health & Services
Links
Providence Brain & Spine Institute Clinical Research
ID
NCT03705351
Phase
Phase 1
Study Type
Interventional
Last Updated