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Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.

Tumor samples from patients treated with TTFields at initial diagnosis.

Tumor samples from patients treated with TTFields at tumor recurrence.

Medical College of Wisconsin Cancer Center Clinical Trials Office

Peter LaViolette

Peter LaViolette, PhD

This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.

RATIONALE:

Optune therapy with tumor treatment fields (TTFields) has recently been FDA approved for the treatment of newly diagnosed glioblastoma due to a recent clinical trial that showed improvement in progression free survival and overall survival compared to standard therapy. (1) TTFields also have a role in the recurrent glioblastoma treatment where it has demonstrated equal efficacy to second-line chemotherapy also has been shown to tumor progression and improve overall survival.(2) Though preclinical studies are ongoing, glioblastoma patients who have undergone TTField therapy have not yet been assessed at autopsy to determine both the pathological signature of TTField treatment, and the pattern of failure. This study will determine how the underlying pathological signatures of tumors treated with TTFields differ from those naïve to TTFields by comparing tumor tissue at autopsy.

STUDY:

All patients undergoing TTField therapy for newly diagnosed and recurrent glioblastoma will be considered for inclusion for this study. The investigators expect to enroll five patients per year for four years, totaling 10 patients treated upfront and 10 patients treated at tumor recurrence. An objective of this study is to determine differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence.

Samples are obtained from regions suspicious for tumor at autopsy.

NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of active cells will be counted computationally.

Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of not active cells will be counted computationally.

Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.

Medical College of Wisconsin

Principal Investigator

All enrolled subjects undergoing Optune therapy.

Standard Magnetic Resonance Imaging (MRI)

Advanced MRI.

Cathy Marszalkowski

Jennifer Connelly, MD

The purpose of this prospective, nonrandomized controlled phase IV study is to compare standard and advanced MRI for their ability to predict response to Optune therapy.

Protocol Summary: Optune therapy is a newly approved treatment for patients with glioblastoma. This therapy demonstrated comparable outcomes for patients with recurrent GBM, in comparison to standard therapies, but better quality of life. More recently, in an interim analysis of 315 patients with GBM, adding Tumor Treating Fields (TTFields) to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival. It also has demonstrated promise in other cancers such as pancreas, mesothelioma, ovarian and lung. However, in order to optimize the treatment regimen, and potentially predict which patients are most likely to respond, reliable ways of evaluation are necessary. Advanced perfusion and diffusion MRI methods have shown utility with other treatments such as bevacizumab. Preliminary data suggests the same might be true for the evaluation of Optune therapy. The team therefore proposes to determine the utility of these methods to predict response to Optune therapy. A successful result will have wide-ranging implications not only for the optimization of Optune treatment of brain cancer but also other cancers shown to benefit from this novel therapy.

Objective: To compare standard and advanced MRI for their ability to predict response to Optune therapy. The team's approach will be to obtain both standard and advanced MRI in patients with newly diagnosed glioblastoma undergoing adjuvant chemotherapy plus Optune therapy. The ability of standard and advanced MRI to predict response will be assessed. The hypothesis is that perfusion and/or diffusion imaging metrics can be used to predict response to and elucidate mechanisms of action for Optune treatment.

Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI

The number of subjects alive at six months.

The number of subjects alive at one year.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy	NCT03194971	Glioblastoma	Tumor samples f... Tumor samples f...	18 Years -	Medical College of Wisconsin
NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy	NCT03194971	Glioblastoma	Tumor samples f... Tumor samples f...	18 Years -	Medical College of Wisconsin
Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI	NCT03297125	Glioblastoma	Standard Magnet... Advanced MRI.	18 Years -	Medical College of Wisconsin

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