NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

Glioblastoma Clinical Trial

Official title:

NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03194971
• Other study ID #: PRO00017446
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: May 31, 2027

Study information

• Verified date: February 2024
• Source: Medical College of Wisconsin
• Contact: Medical College of Wisconsin Cancer Center Clinical Trials Offic
• Phone: 414-805-8900
• Email: cccto[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Froedtert & the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Mitotic Ratio	Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.	At baseline