Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 22 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03705351

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Providence Health & Services

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Ricky Chen, MD
Principal Investigator Affiliation Providence Health and Services

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOtherIndustry
Overall Status Not yet recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Glioblastoma, Cancer of Brain, Glioblastoma Multiforme, Brain Tumor
Study Website: View Trial Website
Additional 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Providence St. Vincent Medical Center, Portland, Oregon

Status

Not yet recruiting

Address

Providence St. Vincent Medical Center

Portland, Oregon, 97225

Site Contact

Tiffany Gervasi-Follmar

tiffany.gervasi@providence.org

503-216-1023

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