Expedited Laser Interstitial Thermal Therapy, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed High Grade Glioma
- Subjects must have suspected high grade glioma by magnetic resonance imaging (MRI)
- Subjects must have received no prior therapies for this disease
- Patients must be considered appropriate candidates for LITT
- Karnofsky performance status >= 60%
- Absolute neutrophil count (ANC) >= 1500 cells/mm^3
- Platelets >= 100,000 cells/mm^3
- Hemoglobin >= 10.0 g/dl; use of transfusion or other intervention to achieve this hemoglobin level is acceptable
- Blood urea nitrogen (BUN) =< 30 mg/dl
- Creatinine =< 1.7 mg/dl
- Bilirubin =< 2.0 mg/dl
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x upper limit of normal
- Electrocardiogram without evidence of acute cardiac ischemia
- Prothrombin time/international normalized ratio (PT INR) < 1.4
- Women of childbearing potential and male participants must practice adequate contraception
- For women of childbearing age, negative pregnancy test within 14 days prior to registration
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
- Patients not eligible to obtain MRI with and without contrast
- Recurrent high grade glioma (HGG)
- Cerebral edema, grade 3 or greater prior to surgery
- Post-operative complications including significant neurological decline or hemorrhage that causes a drop in Karnofsky performance status (KPS) to less than 60 or renders the patient not suitable for chemoradiation as determined by their treating physician
- Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, as determined by the treating physician
- Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
- Subjects receiving other investigational agents
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.
I. To estimate the proportion of patients with pre-LITT radiation plans requiring adjustments in radiation plans post-LITT.
I. To describe changes in the concentration of myeloid derived suppressor cells (MDSCs) and T-cells (CD8+, CD4+ and T-regulatory cells) in peripheral blood before and after LITT.
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 for 5 days per week over 6 weeks. Patients receive temozolomide orally (PO) one hour prior to radiation therapy from day 1 of radiation therapy to the last day of radiation for a maximum of 49 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed up for 10-12 weeks.
Trial Phase Phase O
Trial Type Treatment
Case Comprehensive Cancer Center
Jennifer S. Yu
- Primary ID CASE4316
- Secondary IDs NCI-2016-01900
- Clinicaltrials.gov ID NCT02970448