Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma

NCT04474353 | Completed Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: IRB-53582NCI-2021-06752
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) for newly diagnosed glioblastoma (GBM).

Conditions

Glioblastoma; Newly Diagnosed Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Dose-limiting Toxicity (DLTs)

  Dose limiting toxicities (DLTs) are defined as possibly, probably, or definitely related adverse events that are severe or medically significant, and needing topical \& systemic therapy; needing surgery intervention; needing hospitalization; needing treatment interruption; or life threatening. Late DLTs will be assessed as the number of DLTs that occur in the period from 31 days after the start of treatment through 5 months after the start of treatment. The outcome will be reported as a number without dispersion.

  5 months

Secondary Outcomes (3)

• Acute dose limiting toxicity

  1 month

• Progression-free Survival (PFS) at 6 Months

  6 months

• Overall Survival (OS)

  30 months

Study Arms (1)

Novo-TTF

EXPERIMENTAL

Day 1: Subjects will wear the Optune (TTFields device) for ≥ 18 hours/day. They will take off the device when receiving stereotactic radiosurgery and brain MRI scans. Days 1 to 8: Subjects will take oral temozolomide 75 mg/m2/day Days 2 to 8: Subjects will receive stereotactic radiosurgery (total of 35 Gy) divided equally over 5 days • After the interventional treatment, subjects will receive standard of care adjuvant chemotherapy and routine surveillance brain MRI scans.

Device: Optune; Drug: Gadolinium; Drug: Temozolomide; Radiation: Stereotactic radiosurgery (SRS)

Interventions

Optune DEVICE

Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure

Novo-TTF

Gadolinium DRUG

Gadolinium contrast medium

Also known as: Contrast agent

Novo-TTF

Temozolomide DRUG

Chemotherapy agent

Novo-TTF

Stereotactic radiosurgery (SRS) RADIATION

Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2

Novo-TTF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically proven newly diagnosed glioblastoma (GBM, WHO Grade IV) or molecular GBM of lower grade that will be treated as per glioblastoma (defined as IDH wild type, 1p19q not co deleted)
• Age ≥ 18 years
• A maximum tumor target diameter of less than 5 cm on the post operative MRI used for SRS planning (a 5 mm margin is added in the radiotherapy planning process, yielding a maximum diameter of the planning target volume (PTV) of less than 6 cm). If the maximum diameter is greater than 5 cm, the subject is still eligible if the PTV is less than 113 cm3 which is the volume of a 6 cm diameter sphere.
• Adequate organ function (obtained within 14 days prior to Day 0) as evidenced by:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L without myeloid growth factor support for 7 days preceding the lab assessment
• Hemoglobin (Hgb) ≥ 9 g/dL (90 g/L); \< 9 g/dL (\< 90 g/L) is acceptable if hemoglobin is corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to Day 0
• Platelet count ≥ 100 × 109/L without blood transfusions for 7 days preceding the lab assessment
• Bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with documented history of Gilbert's disease
• Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 × ULN
• Alkaline phosphatase (AP) ≤ 3 × ULN
• Women of childbearing potential (WCBP): negative serum pregnancy test (this test is required of all women unless post menopausal, defined as 12 consecutive months since last regular menses or surgically sterile)
• Ability to tolerate MRI
• Karnofsky Performance Scale (KPS) ≥ 60
• Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document.

You may not qualify if:

• Previous chemotherapy or radiotherapy for glioma
• Concurrent use of experimental therapies
• Known allergy to adhesive tapes or other skin adhesives used in medical care
• Known underlying skin hypersensitivity or other condition of the scalp with potential toxicity per pre treatment dermatology evaluation
• Subjects with the following co morbid disease or incurrent illness:
• Subjects with known cirrhosis diagnosed with Child Pugh Class A or higher liver disease.
• Prior malignancy except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to first dose of investigational drug
• Severe/uncontrolled inter current illness within the previous 28 days prior to first day of treatment
• Subjects who have implantable devices that are contra indicated for use with TTFields
• Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
• Subjects receiving the following medications at the time of combined TTFields and SRS:
• Pharmacotherapy for tuberculosis or HIV as these medications are known to interact with temozolomide
• Other chemotherapy, other investigational agents, or biologic agents for the treatment of cancer including antibodies (eg, bevacizumab, trastuzumab, pertuzumab), small molecules, or any investigational agent(s).
• Pregnant or nursing females will be excluded from the study
• History of inability to tolerate MRI

Sponsors & Collaborators

• Stanford University: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Gadolinium; Contrast Media; Temozolomide; Radiosurgery

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Scott G Soltys

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology (Radiation Therapy)

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: May 21, 2021
• Primary Completion: November 14, 2024
• Study Completion: September 2, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)