This trial studies the effect of laser interstitial thermal therapy (LITT) and hypofractionated radiation therapy in treating patients with grade II-IV glioma that has come back (recurrent) or is growing, spreading, or getting worse (progressive). LITT is performed by implanting a laser catheter into the tumor and heating it to temperatures high enough to kill the tumor. Hypofractionated (short course) radiation therapy is a focused course of radiation treatment that delivers maximum dose to the tumor in a shorter amount of time with minimum toxicity to the normal tissue surrounding the tumor. Giving LITT and hypofractionated radiation therapy may delay or prevent the worsening of the tumor.
Additional locations may be listed on ClinicalTrials.gov for NCT04181684.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Maryland Proton Treatment CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Bel Air
UM Upper Chesapeake Medical CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Columbia
Central Maryland Radiation Oncology in Howard CountyStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Glen Burnie
UM Baltimore Washington Medical Center/Tate Cancer CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
PRIMARY OBJECTIVE:
I. The ability to complete protocol treatment (i.e. LITT and radiation therapy) without undue treatment-related acute toxicity as defined below:
Ia. Safety: < 40% rate of grade 3 or higher neurologic treatment-related toxicity.
IIb. Early stopping rules: Two or more grade 2 or higher symptomatic central nervous system (CNS) hemorrhages; Eight treatment-related grade 3 or higher non-hematologic or grade 4 or higher hematologic treatment related toxicities.
SECONDARY OBJECTIVES:
I. Progression-free survival at 6 months.
II. Median progression-free survival.
III. Median overall survival.
IV. 1-year overall survival.
V. Overall response rate.
VI. Quality of Life assessment.
OUTLINE:
Patients undergo LITT. Within 10 days of LITT, patients also undergo hypofractionated radiation therapy once daily (QD) over 30 minutes, 5 days a week (Monday through Friday) for a total of 10 fractions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, then every 2-3 months for up to 2 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorMark V. Mishra