This phase 0 trial studies the side effects and how well shortening the time between laser interstitial thermal therapy, radiation therapy, and temozolomide works in treating patients with newly diagnosed high grade glioma. Laser interstitial thermal therapy uses a laser to kill tumor cells by heating them. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Shortening the time between laser interstitial thermal therapy, radiation therapy, and temozolomide may kill tumor cells more effectively in patients with high grade glioma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02970448.
PRIMARY OBJECTIVE:
I. To determine the safety and feasibility of reducing the time interval between laser interstitial thermal therapy (LITT) and the start of chemoradiation to =< 7 days.
SECONDARY OBJECTIVE:
I. To estimate the proportion of patients with pre-LITT radiation plans requiring adjustments in radiation plans post-LITT.
CORRELATIVE OBJECTIVE:
I. To describe changes in the concentration of myeloid derived suppressor cells (MDSCs) and T-cells in peripheral blood.
OUTLINE:
Patients undergo laser interstitial thermal therapy. Within 7 days after surgery, patients undergo three-dimensional conformal radiotherapy (3D-CRT) or intensity modulation radiation therapy (IMRT) daily, Monday through Friday for 30 or 15 treatments. Patients receive temozolomide orally (PO) one hour prior to radiation therapy from day 1 of radiation therapy to the last day of radiation and may be given for up to 5 days after completion of radiation in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed up for 10-12 weeks.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorJennifer S. Yu
