RecruitingInterventional

Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.

NCT ID: NCT04181684Sponsor: University of Maryland, BaltimoreLast updated: 2026-01-23

Summary

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.

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.

Arms & interventions

DeviceProcedure: LITT
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
RadiationHypo-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.

Outcome measures

Primary

Adverse Events
To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy.
Time frame: 2 years

Secondary

Progression-free survival at 6 months
Time frame: 2 Years
Median progression-free survival
Time frame: 2 Years
Median overall survival
Time frame: 2 years
1-year overall survival
Time frame: 2 years
Overall response rate
Time frame: 2 years
Quality of Life before, during, and after treatment
Time frame: 2 years

Eligibility criteria

Sex: AllAge: 22 Years and olderHealthy volunteers: No

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