Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nicholas Fidelman, MD
Headshot of Nicholas Fidelman
Nicholas Fidelman

Description

Summary

The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.

Official Title

FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM

Details

Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in <7% of patients surviving to five years post-diagnosis. External beam radiotherapy is currently a mainstay treatment for GBM; however, the dose delivered is limited by side effects. The targeted radiotherapy of the TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) has promising potential to provide GBM patients with reduced side effects compared to external beam radiotherapy as well as a more effective treatment for this catastrophic disease. The TheraSphere GBM device utilized in the FRONTIER trial is an yttrium-90 (Y-90) glass microsphere therapy for selective internal radiation therapy (endovascular radiotherapy) in recurrent GBM patients as a neoadjuvant to surgery. The TheraSphere GBM treatment utilizes intra-arterial delivery and takes advantage of blood flow and direct tumor delivery. Treatment can be delivered by specific placement of a catheter close to the tumor through known angiographic techniques currently utilized by neuro-endovascular or interventional radiology physicians. Angiographic evaluation prior to treatment allows identification of tumor feeding arteries and definition of the treatment volume. TheraSphere GBM could achieve a high tumor response rate based on delivery of a tumor absorbed dose that is not currently possible with EBRT. In consideration of the potential benefit of a more localized, targeted treatment with a reduced side effect profile compared to other treatment options, and the potential impact on patients' quality of life for this devastating disease, this First-in-Human Early Feasibility Study (EFS) of the TheraSphere GBM Y-90 Glass Microsphere System for the treatment of recurrent GBM is being conducted.

Keywords

Glioblastoma Multiforme Recurrent Glioblastoma Glioblastoma Recurrence TheraSphere GBM

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
  2. Life expectancy ≥ 12 weeks
  3. Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule
  4. History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria
  5. Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria
  6. Prior surgery and treatment with combination of radiotherapy and chemotherapy + Tumor Treating Fields (Optune®)
  7. Prior cranial radiation dose < 66 Gy
  8. WHO performance status ≤ 2
  9. The interval since completion of cranial radiotherapy must be > 6 months, unless there is tissue confirmation of tumor recurrence/progression outside the previous radiation treatment field, in which case the interval since completion of cranial radiation must be at least 12 weeks
  10. . Interval since last cytotoxic therapy until presumed date of intervention ≥ 1 cycle or ≥ 2 biological half-lives, i.e.
  11. ≥ 4 weeks since last dose of temozolomide
  12. ≥ 6 weeks since last dose of lomustine or other nitrosourea
  13. ≥ 2 weeks since last dose of a small molecule targeted agent
  14. ≥ 12 weeks from last dose of last bevacizumab infusion, Tyrosine Kinase Inhibitor, or other anti VEGFR therapy
  15. . If receiving steroids, patient should be on a stable or decreasing dose equivalent to dexamethasone ≤ 6 mg/d, for at least 7 days prior to registration
  16. . Have adequate organ and bone marrow function within 14 days prior to registration, as defined below:
  17. INR ≤ 1.2 (in absence of anticoagulation)
  18. Platelets ≥ 100,000/L
  19. Creatinine ≤1.5 mg/dL
  20. Absolute Neutrophil Count ≥1.5 x 109/L
  21. Hemoglobin ≥9.0 g/dL
  22. . Have a negative pregnancy test within 14 days prior to registration on study (for FOCBP, female of child-bearing potential)
  23. . Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator
  24. . Angiographic Mapping Inclusion Criteria:
  25. Accessible neurovascular anatomy that allows for safe microcatheter placement (single location) to infuse TheraSphere GBM to treat all of the T1 enhancing component of lesion confirmed by neuro-interventional team.
  26. Treatment volume is ≤ 150cc in the non-dominant hemisphere and non-eloquent regions as determined by multidisciplinary team. Eloquent regions should be defined as areas of the brain that maintain language, vision, sensory and motor function

You CAN'T join if...

  1. Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor approximating or invading the brainstem and/or optic chiasma, leptomeningeal disease, or extracranial metastatic disease
  2. Have received more than 1 course of prior radiotherapy (EBRT)
  3. Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy
  4. Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide
  5. Have received more than 2 surgical GBM-related procedures
  6. Have received prior thoracic radiation therapy
  7. Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. brain surgery within the last 3 months, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)
  8. Have uncontrolled epilepsy
  9. Have severe and/or insufficiently controlled intercurrent illness; patients with the following are not eligible:
  10. Hypertension grade 3 or higher without adequate control on medications
  11. Symptomatic or unstable cardiac disease, known to have right-to-left shunts, or severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg)
  12. Pulmonary insufficiency (arterial oxygen pressure (Pa,O2) of < 60 mmHg, or oxygen saturation (Sa,O2) of < 90%) as measured by fingertip pulse oximeter
  13. Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)
  14. Pneumonitis
  15. Psychiatric illness/social situations that would limit compliance with study requirements
  16. Peripheral Neuropathy ≥ grade 1
  17. Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety, study endpoints or longevity
  18. . Are currently pregnant or breast feeding (unless patient agrees to stop breastfeeding)
  19. . Patients with a history of an active other malignancy within 1 year prior to registration. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease, or recurrent glioblastoma
  20. . Patients with a history of ischemic cerebral disease and/or at risk of cerebral herniation
  21. . Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)
  22. . Known history of hypersensitivity reactions to iodinated and/or gadolinium-based contrast
  23. . Subject has received any other investigational agents within 4 weeks of treatment, or is currently participating, or plans to participate in, another

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Northwestern Univerity accepting new patients
    Chicago Illinois 60611 United States

Lead Scientist at UCSF

  • Nicholas Fidelman, MD
    Nicholas Fidelman, MD, is a Professor of Clinical Radiology at the University of California, San Francisco and UCSF Mount Zion. Dr. Fidelman received his medical degree from UCSF in 2002, and completed his residency in Diagnostic Radiology from UCSF in 2007, followed by a fellowship in Interventional Radiology from UCSF in 2008.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT05303467
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 12 study participants
Last Updated