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
2 other identifiers
interventional
30
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started May 2018
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedStudy Start
First participant enrolled
May 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2024
CompletedMay 15, 2025
May 1, 2025
3 years
March 19, 2018
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
NovoTTF-200A device discontinuation rate due to skin toxicity
Discontinuation events are defined as the discontinuation of NovoTTF-200A device for \> 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.
Up to 30 days after finishing chemoradiation treatment
Secondary Outcomes (3)
Progression-free survival
From enrollment up to 1 year
Overall survival
From enrollment up to 1 year
Event-free survival
From enrollment up to 1 year
Study Arms (1)
Treatment (temozolomide, radiation, NovoTTF-200A device)
EXPERIMENTALParticipants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Undergo radiation therapy
Undergo tumor treatment fields therapy using NovoTTF-200A device
Undergo tumor treatment fields therapy using NovoTTF-200A device
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Publications (3)
Ali AS, Lombardo J, Niazi MZ, Miller RC, Alnahhas I, Martinez NL, Andrews DW, Judy KD, Shi W. Concurrent chemoradiation and Tumor Treating Fields (TTFields, 200 kHz) for patients with newly diagnosed glioblastoma: patterns of progression in a single institution pilot study. J Neurooncol. 2022 Nov;160(2):345-350. doi: 10.1007/s11060-022-04146-w. Epub 2022 Nov 10.
PMID: 36355259DERIVEDMiller R, Song A, Ali A, Niazi M, Bar-Ad V, Martinez N, Glass J, Alnahhas I, Andrews D, Judy K, Evans J, Farrell C, Werner-Wasik M, Chervoneva I, Ly M, Palmer J, Liu H, Shi W. Scalp-Sparing Radiation With Concurrent Temozolomide and Tumor Treating Fields (SPARE) for Patients With Newly Diagnosed Glioblastoma. Front Oncol. 2022 Apr 29;12:896246. doi: 10.3389/fonc.2022.896246. eCollection 2022.
PMID: 35574391DERIVEDSong A, Bar-Ad V, Martinez N, Glass J, Andrews DW, Judy K, Evans JJ, Farrell CJ, Werner-Wasik M, Chervoneva I, Ly M, Palmer JD, Liu H, Shi W. Initial experience with scalp sparing radiation with concurrent temozolomide and tumor treatment fields (SPARE) for patients with newly diagnosed glioblastoma. J Neurooncol. 2020 May;147(3):653-661. doi: 10.1007/s11060-020-03466-z. Epub 2020 Mar 23.
PMID: 32206976DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenyin Shi, MD
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
March 26, 2018
Study Start
May 4, 2018
Primary Completion
April 21, 2021
Study Completion
January 26, 2024
Last Updated
May 15, 2025
Record last verified: 2025-05