ClinicalTrials.gov
ClinicalTrials.gov Menu

LITT Palliative Treatment for Patients With Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03176160
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Monteris Medical
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment
Malignant Glioma of Brain Glioblastoma 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
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Interstitial Thermal Therapy (LITT) as Palliative Treatment for Patients With Malignant Glioma Requiring Standard Treatment Alternatives
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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 Name: NBS NeuroBlate® System




Primary Outcome Measures :
  1. Change in NCCN distress thermometer score [ Time Frame: Up to 24 months after the LITT procedure ]
    Mean change from baseline in the NCCN distress thermometer score


Secondary Outcome Measures :
  1. Median overall survival [ Time Frame: 24 months after LITT ]
    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.

  2. Change in Karnofsky Performance Status (KPS) [ Time Frame: Up to 24 months after the LITT procedure ]
    Mean change from baseline in KPS score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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

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): NCT03176160


Contacts
Contact: Peter Fecci, MD, PhD 919-681-8977 dukebrain1@dm.duke.edu
Contact: Elwood Massey, BS, MDiv 919-684-5301 dukebrain1@dm.duke.edu

Locations
United States, North Carolina
The Preston Robert Tisch Brain Tumor Center at Duke Recruiting
Durham, North Carolina, United States, 27710
Contact: Peter Fecci, MD, PhD    919-681-8977    dukebrain1@dm.duke.edu   
Contact: Elwood Massey, BS, MDiv    919-684-5301    dukebrain1@dm.duke.edu   
Principal Investigator: Peter Fecci, MD, PhD         
Principal Investigator: Katherine Peters, MD, PhD         
Sponsors and Collaborators
Duke University
Monteris Medical
Investigators
Principal Investigator: Peter S Fecci, MD, PhD Duke University

Additional Information:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03176160     History of Changes
Other Study ID Numbers: Pro00079623
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Duke University:
LITT
Fecci
Pro00079623
Glioblastoma
Laser Interstitial Thermal Therapy
Palliative

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