Status:
COMPLETED
Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
NovoCure Ltd.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 g...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03477110
Start Date
May 4 2018
End Date
January 26 2024
Last Update
May 15 2025
Active Locations (1)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107