NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

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

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Device: Tumor samples from patients treated with TTFields at tumor recurrence.; Other: Tumor samples from patients treated with TTFields at initial diagnosis.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Medical College of Wisconsin Cancer Center Clinical Trials Office; Phone Number: 414-805-8900; Email: cccto@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert & the Medical College of Wisconsin
      • Contact: Peter LaViolette; Phone Number: 414-456-7490; Email: plaviole@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newly Diagnosed Glioblastoma Patients undergoing standard of care treatment consisting of surgery followed by chemo-radiation therapy will have the addition of Optune TTField therapy together with adjuvant chemotherapy. OR Recurrent Glioblastoma Patients with glioblastoma tumor recurrence defined by either imaging criteria, or deteriorating neurological function will be offered Optune TTField treatment at the discretion of the neurooncologist.

Description

Inclusion Criteria:

• Newly diagnosed glioblastoma, World Health Organization (WHO) grade IV, patients undergoing TTField therapy.
• Recurrent glioblastoma WHO grade IV, patients undergoing TTField therapy.

Exclusion Criteria:

• TTField compliance < 75%.
• Any contraindication to Optune TTField treatment.
• Initial brain tumor diagnosis < WHO grade IV.
• Duration of TTField therapy < 3 months.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TTField at Recurrence	Device: Tumor samples from patients treated with TTFields at tumor recurrence.; 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.
TTField at New Diagnosis	Other: Tumor samples from patients treated with TTFields at initial diagnosis.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mitotically active cells	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.	At baseline
Number of mitotically inactive cells	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.	At baseline
Mitotic Ratio	Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.	At baseline

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Peter LaViolette, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: glioblastoma; brain tumor autopsy; autopsy; Optune therapy; tumor treatment fields; TTFields; Recurrent glioblastoma; grade IV; brain tumor; newly diagnosed glioblastoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: PRO00017446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No