Clinical trial NCT03176160: LITT Palliative Treatment for Patients With Malignant Gliomas
Official title: Laser Interstitial Thermal Therapy (LITT) as Palliative Treatment for Patients With Malignant Glioma Requiring Standard Treatment Alternatives
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Malignant Glioma of Brain
Glioblastoma
Keywords: LITT
Fecci
Pro00079623
Glioblastoma
Laser Interstitial Thermal Therapy
Palliative
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Monteris Medical
First posted: 2017-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed WHO grade IV malignant glioma who are unable to undergo broader surgical resection and are identified as approved to receive the LITT procedure

Brief summary: The purpose of this study is to to describe the effect of a palliative regimen consisting of Laser Interstitial Thermal Therapy (LITT) on distress, quality of life (QOL), neurocognition, days in the hospital, patient disposition, and readmission in newly diagnosed World Health Organization (WHO) grade IV malignant glioma (glioblastoma (GBM) or gliosarcoma) patients unable to undergo broader surgical resection. The primary objective is to assess changes in the National Comprehensive Cancer Network (NCCN) distress thermometer in newly diagnosed WHO grade IV malignant glioma patients who receive LITT.

\*Please note: This study was originally designed as a interventional device study studying the effect of the LITT procedure; however, it was re-designed as an observational study in which the patient population being studied is approved to receive the LITT procedure.

Detailed description: Patients will be identified from those previously approved for the LITT procedure. Following consent, 20 patients will complete NCCN distress, Quality of Life (QOL) and neuro-cognitive baseline testing, followed by the LITT procedure using the NeuroBlate® System (NBS) and intra-operative magnetic resonance imaging (MRI). Per standard clinical practice, after completing LITT, patients will undergo radiation at the discretion of the treating radiation oncologist. Patients will likewise receive concomitant and adjuvant chemotherapy (typically temozolomide) at the discretion of the treating neuro-oncologist. All patients will complete NCCN distress, QOL and neurocognitive testing immediately after the LITT procedure on post-operative day 1 as able, or immediately prior to discharge if more appropriate. Additionally, they will complete these same tests approximately 1, 3, 6, 12, and 24 months after the completion of LITT therapy.

Eligibility criteria: Inclusion Criteria:

* Patient with histopathologically confirmed newly diagnosed WHO grade IV malignant glioma (GBM or gliosarcoma, multifocal disease is allowed) unable to undergo surgical resection, who is approved and scheduled to receive the LITT procedure by the treating neurosurgeon
* ≥18 years of age
* Patient is "fragile" (age 18-69, KPS 50-70), "elderly" (age \> 69, KPS 80-100), or "elderly and fragile" (age \> 69, KPS 50-70)
* Patient must not have received prior chemotherapy or brain radiotherapy
* Patient is able and willing to complete the QOL and neurocognitive questionnaires. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. If patients are not able to read or write, proxy interviews will be conducted in-person or via telephone by the assigned study clinician or study team member (Trail-Making A \& B will not be performed on these patients).
* Patient consent must be obtained according to Duke institutional policy
* Patient must be accessible for follow-up

Exclusion Criteria:

* Non-English speaking or inability to read and understand English
* Patients with concurrent malignancies requiring active treatment, except: non-melanoma skin cancer, or in-situ cancer of the cervix.
* Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol-related QOL and distress questionnaires and cognition assessments

Primary outcomes:
measure: Change in NCCN distress thermometer score
timeFrame: Up to 24 months after the LITT procedure
Secondary outcomes:
measure: Median overall survival
timeFrame: 24 months after LITT
measure: Change in Karnofsky Performance Status (KPS)
timeFrame: Up to 24 months after the LITT procedure
Other outcomes:
Locations:
city: Durham
country: United States
facility: The Preston Robert Tisch Brain Tumor Center at Duke
state: North Carolina
Study officials:
affiliation: Duke University
name: Peter S Fecci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: