LITT Palliative Treatment for Patients With Malignant Gliomas

Laser Interstitial Thermal Therapy (LITT) as Palliative Treatment for Patients With Malignant Glioma Requiring Standard Treatment Alternatives

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.

Study Overview

• Status: Withdrawn
• Conditions: Glioblastoma; Malignant Glioma of Brain
• Intervention / Treatment: Other: Palliative regimen consisting of LITT

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • The Preston Robert Tisch Brain Tumor Center at Duke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving palliative regimen consisting of LITT; Patients with WHO grade IV malignant glioma who are approved for and receive the LITT (Laser Interstitial Thermal Therapy) procedure	Other: Palliative regimen consisting of LITT; Minimally invasive technique to necrotize intracranial lesions; Other Names: NBS NeuroBlate® System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NCCN distress thermometer score	Mean change from baseline in the NCCN distress thermometer score	Up to 24 months after the LITT procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median overall survival	Overall survival will be defined as the time in months between Laser Interstitial Thermal Therapy (LITT) and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.	24 months after LITT
Change in Karnofsky Performance Status (KPS)	Mean change from baseline in KPS score	Up to 24 months after the LITT procedure

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Monteris Medical
• Investigators: Principal Investigator: Peter S Fecci, MD, PhD, Duke University

Publications and helpful links

Helpful Links

• The Preston Robert Tisch Brain Tumor Center at Duke
• Duke Cancer Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (ACTUAL): June 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Glioblastoma; Palliative; LITT; Laser Interstitial Thermal Therapy; Fecci; Pro00079623
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma
• Other Study ID Numbers: Pro00079623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No