NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2018
Start Date:June 1, 2017
End Date:May 31, 2022
Contact:Medical College of Wisconsin Cancer Center Clinical Trials Office
Email:cccto@mcw.edu
Phone:414-805-8900

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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.

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.
We found this trial at
1
site
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Phone: 414-456-7490
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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mi
from
Milwaukee, WI
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