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NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

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

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.


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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

Resource links provided by the National Library of Medicine


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.




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.


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194971


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

Locations
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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
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Principal Investigator: Peter LaViolette, PhD Medical College of Wisconsin

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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    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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