NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

• ClinicalTrials.gov Identifier: NCT03194971
• Recruitment Status: Recruiting
• First Posted: June 21, 2017
• Last Update Posted: November 19, 2019
• Sponsor: Medical College of Wisconsin
• Information provided by (Responsible Party): Peter LaViolette, Medical College of Wisconsin

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Glioblastoma	Other: Tumor samples from patients treated with TTFields at initial diagnosis.; Other: Tumor samples from patients treated with TTFields at tumor recurrence.

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 Design

• Study Type: Observational
• Estimated Enrollment: 20 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: May 31, 2021
• Estimated Study Completion Date: May 31, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
TTField at Recurrence	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.; Other: 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.; Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Underlying pathological signatures of TTField therapy compared to patients naïve to TTField therapy using pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells . [ Time Frame: Through completion of study, an average of four years. ]
   Tissue samples will be obtained at autopsy.

Secondary Outcome Measures :

1. 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 using pathological assessment. [ Time Frame: Through completion of study, an average of four years. ]
   Tissue samples will be obtained at autopsy. Pathological assessment of of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed.

Biospecimen Retention:   Samples Without DNA

Samples are obtained from regions suspicious for tumor.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

Inclusion Criteria:

• Newly diagnosed glioblastoma, 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.

Contacts and Locations

Contacts

Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office; 414-805-8900; cccto@mcw.edu

Locations

United States, Wisconsin

Froedtert & the Medical College of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Peter LaViolette 414-456-7490 plaviole@mcw.edu

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

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

More Information

• Responsible Party: Peter LaViolette, Principal Investigator, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT03194971 History of Changes
• Other Study ID Numbers: PRO00017446
• First Posted: June 21, 2017
• Last Update Posted: November 19, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter LaViolette, Medical College of Wisconsin:

glioblastoma; brain tumor autopsy; autopsy; Optune therapy; tumor treatment fields; TTFields; Recurrent glioblastoma; grade IV; brain tumor; newly diagnosed glioblastoma

Additional relevant MeSH terms:

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