LITT Followed by Hypofractionated RT for Recurrent Gliomas
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.
Conditions:
🦠 Glioblastoma 🦠 Brain Tumor 🦠 Glioma 🦠 Neoplasms
🗓️ Study Start (Actual) 8 January 2020
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 32
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States
📍 Bel Air, Maryland, United States
📍 Columbia, Maryland, United States
📍 Glen Burnie, Maryland, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
    • * Patient must have received prior radiation therapy for initial treatment of glioma
    • * Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
    • 2. Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
    • 3. History and physical including neurological exam within 30 days prior to registration
    • 4. Karnofsky performance status ≥ 60% within 30 days prior to registration
    • 5. Age ≥ 22 years old
    • 6. Minimum interval since completion of prior radiation treatment is 8 weeks
    • * Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
    • 7. Patients must have signed an approved informed consent
    • 8. Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
    • 9. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

    Exclusion Criteria:

    • 1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation
    • 2. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    • * History or presence of serious uncontrolled ventricular or significant arrhythmias.
    • * Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
    • 3. Infratentorial tumor or evidence of leptomeningeal spread
    • 4. Inability to undergo a MRI
    • 5. Pregnant or breast-feeding women
Ages Eligible for Study: 22 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 November 2019
  • First Submitted that Met QC Criteria 26 November 2019
  • First Posted 29 November 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 May 2024
  • Last Update Posted 7 May 2024
  • Last Verified May 2024