LITT Palliative Treatment for Patients With Malignant Gliomas

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03176160
• Other study ID #: Pro00079623
• Status: Withdrawn
• Start date: June 2019
• Est. completion date: June 2022

Study information

• Verified date: February 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Malignant Glioma of Brain

Intervention

Other:
• Palliative regimen consisting of LITT
Minimally invasive technique to necrotize intracranial lesions

Locations

Country	Name	City	State
United States	The Preston Robert Tisch Brain Tumor Center at Duke	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Monteris Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in Karnofsky Performance Status (KPS)	Mean change from baseline in KPS score	Up to 24 months after the LITT procedure

External Links

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