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Expedited Laser Interstitial Thermal Therapy, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed High Grade Glioma

Trial Status: Active

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Contact: Jennifer S. Yu
Phone: 216-445-9799
Email: yuj2@ccf.org

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 (CD8+, CD4+ and T-regulatory cells) in peripheral blood before and after LITT.

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 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

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Jennifer S. Yu

  • Primary ID CASE4316
  • Secondary IDs NCI-2016-01900
  • Clinicaltrials.gov ID NCT02970448