NCT03477110CompletedEarly phase 1
Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
SPARE-Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study
Source: ClinicalTrials.gov · Last updated 15 May 2025
Brief summary (registry, in English)
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 glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 19 Mar 2018
- Start date
- 4 May 2018
- Primary completion date
- 21 Apr 2021
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Diseases
- Glioblastoma
- NCT number
- NCT03477110
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 30
- From 4 May 2018 to the primary completion date, 21 Apr 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation treatment to the brain
- Prior treatment with temozolomide
Other illness
- Infratentorial disease (defined as glioblastoma \[GBM\] derived from cerebellum or brainstem)
- Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator
- 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
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.