Feasibility Study on LITT for Newly Diagnosed Glioblastoma (FLAG)

• ClinicalTrials.gov Identifier: NCT02880410
• Recruitment Status: Terminated
• First Posted: August 26, 2016
• Last Update Posted: August 14, 2019
• Sponsor: Monteris Medical
• Information provided by (Responsible Party): Monteris Medical

Study Description

Brief Summary:

Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).

Condition or disease	Intervention/treatment	Phase
Glioblastoma	Device: NeuroBlate System; Drug: Radiation therapy and temozolomide	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
• Actual Study Start Date: August 15, 2017
• Actual Primary Completion Date: September 14, 2018
• Actual Study Completion Date: September 14, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: LITT Treatment w/radiation therapy and temozolomide; This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide	Device: NeuroBlate System; Laser Interstitial Thermal Therapy; Drug: Radiation therapy and temozolomide; Radiation therapy and temozolomide

Outcome Measures

Primary Outcome Measures :

1. Adverse Events [ Time Frame: 2 Years ]
   Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.

Secondary Outcome Measures :

1. Progression-Free Survival Rate [ Time Frame: 2 Years ]
   To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System
2. Overall Survival [ Time Frame: 2 Years ]
   To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System
3. Changes in Quality of Life [ Time Frame: 2 Years ]
   Characterize the changes in quality of life in subjects with newly diagnosed glioblastoma who are undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools

Eligibility Criteria

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

Criteria

Relevant Inclusion Criteria:

1. Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy
2. Single enhancing lesion that is >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)
3. The patient must be ≥18 years of age
4. KPS > 70
5. Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.
6. Stable cardiovascular, pulmonary health status

Relevant Exclusion Criteria:

1. Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
2. Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant
3. Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
4. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
5. Pregnancy, or planning to become pregnant
6. Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects
7. Patients with multiple or multifocal GBM

Contacts and Locations

Locations

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

United States, North Carolina

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

Monteris Medical

Investigators

• Principal Investigator: Manmeet Ahluwalia, MD; The Cleveland Clinic
• Principal Investigator: Sujit Prabhu, MD; M.D. Anderson Cancer Center

More Information

• Responsible Party: Monteris Medical
• ClinicalTrials.gov Identifier: NCT02880410 History of Changes
• Other Study ID Numbers: FLAG
• First Posted: August 26, 2016
• Last Update Posted: August 14, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Monteris Medical:

Glioblastoma; NeuroBlate; LITT; Quality of Life

Additional relevant MeSH terms:

Glioblastoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Temozolomide; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents