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LASR (LITT and Short Course XRT) (LASR)

This study is not yet open for participant recruitment.
Verified September 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176160
First Posted: June 5, 2017
Last Update Posted: September 29, 2017
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.
Collaborator:
Monteris Medical
Information provided by (Responsible Party):
Duke University
  Purpose
The purpose of this study is to determine if Laser Interstitial Thermal Therapy (LITT) is safe in newly diagnosed glioblastoma (GBM) patients unable to undergo broader surgical resection. LITT, and specifically the NeuroBlate® System (NBS), represents a unique tool that may permit the development of much needed novel treatment algorithms for those GBM patients inappropriate for the conventional surgery followed by chemotherapy and radiation. The primary objective is to assess the safety of combination LITT and short-course radiation therapy (SCRT) for patients with newly diagnosed GBM not amenable to standard of care (SOC) therapy.

Condition Intervention
Malignant Glioma of Brain Glioblastoma Procedure: Laser Interstitial Thermal Therapy (LITT) Radiation: Short-Course Radiation Therapy (SCRT) Device: NeuroBlate® System (NBS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LASR: LITT And Short Course Radiation for Patients With GBM Requiring Standard Treatment Alternatives

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Percentage of patients with unacceptable toxicity [ Time Frame: 4 weeks after the LITT procedure ]
    The primary outcome is the percentage of participants experiencing unacceptable toxicity in the four weeks after LITT procedure. Toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4 criteria. An unacceptable toxicity is defined as any Grade IV or V neurologic system disorder, including but not limited to, any of the following adverse events that occur within the first 4 weeks after LITT treatment: intracranial bleed requiring intervention; treatment-related herniation, irreversible coma, or death; elevations in increased intracranial pressure (ICP) or extensive edema requiring decompression; post-operative wound infection. Cerebral edema will not constitute an unacceptable toxicity unless it requires surgical decompression.


Secondary Outcome Measures:
  • Median overall survival [ Time Frame: 2 years 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.

  • The percentage of participants alive and without disease progression 6 months after the Laser Interstitial Thermal Therapy (LITT) procedure [ Time Frame: 6 months after LITT ]
    The percentage of participants alive and without disease progression 6 months after the LITT procedure. Progression-free survival is defined as the time from LITT until disease progression or death, or until the date of last follow-up if the patient is alive without disease progression. Kaplan-Meier methods will be used to estimate progression-free survival.


Estimated Enrollment: 20
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LITT followed by SCRT
Laser Interstitial Thermal Therapy (LITT) followed within 7 days by Short-Course Radiation Therapy (SCRT)
Procedure: Laser Interstitial Thermal Therapy (LITT)
LITT is a minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)
Radiation: Short-Course Radiation Therapy (SCRT)
5 Gray (Gy) daily fractions administered over 5 consecutive days
Device: NeuroBlate® System (NBS)
NBS is a minimally invasive robotic laser thermo-therapy tool that is manufactured by Monteris Medical, Inc.

Detailed Description:

Following consent, 20 patients will undergo quality of life (QOL) and neurocognitive baseline testing, followed by LITT using the NBS and intra-operative magnetic resonance imaging (MRI). Within 7 days of LITT, patients will initiate SCRT. Dose for radiation therapy (RT) will be prescribed to the maximum isodose line completely encompassing the target volume using the guidelines established in Radiation Therapy Oncology Group (RTOG) 0320. Fractionated therapy (i.e. 5 Gray/fraction x 5 daily fractions) is permitted as dictated by safety guidelines for a given lesion. Following SCRT, patients may be treated with adjuvant (preferably 50 mg /m2/daily) temozolomide (TMZ) cycles up to 12 months at the discretion of the treating oncologist based on standardized eligibility criteria. QOL and neurocognitive testing will be repeated at SOC clinic visits 1, 3, 6, 12, and 24 months following LITT operation. The study population includes newly diagnosed GBM patients who are unable to undergo broader surgical resection.

For the primary objective of safety, the analysis set will include: (1) patients who experience an unacceptable toxicity attributable to LITT or SCRT treatment during the 4 weeks after initiation of LITT treatment, and (2) patients who complete LITT and SCRT treatment and are observed for 4 weeks after initiation of LITT treatment. Other safety analyses will include all patients who receive LITT treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically confirmed newly diagnosed glioblastoma (GBM) World Health Organization (WHO) Grade IV.

Multifocal GBM is allowed.

  • ≥18 years of age.
  • Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,500 cells/µl, platelets ≥ 125,000 cells/µl.
  • Serum creatinine ≤ 1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) and bilirubin ≤ 1.5 times upper limit of normal.
  • Patient is "fragile" (age 18-69, Karnofsky Performance Status (KPS) 50-70), "elderly" (age > 69, KPS 80-100), or "elderly and fragile" (age > 69, KPS 50-70).
  • Female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intrauterine device (IUD) [only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 2 months following the last trial intervention. Female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to LITT operation per standard of care.
  • Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonal], sexual abstinence or prior vasectomy) during the trial and for a period of > 2 months following the last administration of trial therapy.
  • Patients may have received and continue to receive corticosteroids.
  • Patients 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 (Trailmaking A & B will not be performed on these patients).
  • Patient consent must be obtained according to Duke institutional policy.
  • Patients must be accessible for treatment and follow-up.

Exclusion Criteria:

  • 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 receive protocol treatment or comply with protocol.
  • Pregnant or breast-feeding.
  • Patients with known potentially anaphylactic allergic reactions to gadolinium-diethylenetriamine pentaacetic acid (DTPA).
  • Patients who cannot undergo MRI or SPECT due to obesity or to having certain metal in their bodies (specifically pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates).
  Contacts and Locations
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 Not yet 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
  More Information

Additional Information:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03176160     History of Changes
Other Study ID Numbers: Pro00079623
First Submitted: May 30, 2017
First Posted: June 5, 2017
Last Update Posted: September 29, 2017
Last Verified: September 2017
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:
LASR
Fecci
Pro00079623
Glioblastoma
Laser Interstitial Thermal Therapy
short-course radiation therapy

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