LITT Palliative Treatment for Patients With Malignant Gliomas

NCT03176160 | Withdrawn

• 1 other identifier: Pro00079623
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma of Brain; Glioblastoma

Keywords

LITT; Fecci; Pro00079623; Glioblastoma; Laser Interstitial Thermal Therapy; Palliative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Median overall survival

  24 months after LITT

• Change in Karnofsky Performance Status (KPS)

  Up to 24 months after the LITT procedure

Study Arms (1)

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

Interventions

Palliative regimen consisting of LITT OTHER

Minimally invasive technique to necrotize intracranial lesions

Also known as: NBS NeuroBlate® System

Patients receiving palliative regimen consisting of LITT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Monteris Medical: collaborator

Study Sites (1)

The Preston Robert Tisch Brain Tumor Center at Duke

Durham, North Carolina, 27710, United States

Location

Related Links

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

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter S Fecci, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 5, 2017
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2022
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)