LITT Followed by Hypofractionated RT for Recurrent Gliomas

Purpose

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

Eligibility

Eligible Ages
Over 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
  2. Patient must have received prior radiation therapy for initial treatment of glioma
  3. Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
  4. Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
  5. History and physical including neurological exam within 30 days prior to registration
  6. Karnofsky performance status ≥ 70% within 30 days prior to registration
  7. Age ≥ 22 years old
  8. Minimum interval since completion of prior radiation treatment is 8 weeks
  9. Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
  10. Patients must have signed an approved informed consent
  11. 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.
  12. 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:
  3. History or presence of serious uncontrolled ventricular or significant arrhythmias.
  4. 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
  5. Infratentorial tumor or evidence of leptomeningeal spread
  6. Inability to undergo a MRI
  7. Pregnant or breast-feeding women

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental: LITT with Hypofractionated radiation therapy
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
  • Device: Procedure: LITT
    This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
    Other names:
    • Laser Interstitial thermal therapy
  • Radiation: Hypo-Fractionated Radiation Therapy
    Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.

Recruiting Locations

University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Mark Mishra, MD
410-328-6080

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Mark Mishra, MD
410-328-6080
mmishra@umm.edu

Detailed Description

Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.