Clinical trial NCT03194971: NovoTTF Treatment Signatures in Glioblastoma Patients At Autopsy
Official title: NovoTTF Treatment Signatures in Glioblastoma Patients At Autopsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma
Keywords: glioblastoma
brain tumor autopsy
autopsy
Optune therapy
tumor treatment fields
TTFields
Recurrent glioblastoma
grade IV
brain tumor
newly diagnosed glioblastoma
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of mitotically active cells
timeFrame: At baseline
measure: Number of mitotically inactive cells
timeFrame: At baseline
measure: Mitotic Ratio
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Peter LaViolette, PhD
role: PRINCIPAL_INVESTIGATOR
References: