Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: Johns Hopkins University; National Cancer Institute (NCI); University of Miami
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

• Patients must have a newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically by a board-certified neuropathologist

• Patients must be able to have MRI scans

• Patients must have the following lab values ≤ 14 days prior to registration:

• White blood cell (WBC) ≥ 3,000/µL

• Absolute neutrophil count (ANC) ≥ 1,500/µL

• Platelet count of ≥ 75,000/µL

• Hemoglobin ≥ 9.0 gm/dL (transfusion is allowed to reach minimum level)

• Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.0 x upper limit of normal (ULN)

• Bilirubin ≤ 2 x ULN

• Creatinine ≤ 1.5 mg/dL

• Patients must have a life expectancy of ≥ 12 weeks

• Patients must have a Karnofsky performance status (KPS) ≥ 60

• Patients who are women of childbearing potential must have a negative pregnancy test documented ≤ 14 days prior to registration; this is not specific to dose escalation and is mandatory for standard care for patients being treated with radiation therapy; the cost of this test will be covered by standard of care

• Patients must be able to understand and provide written informed consent

• Members of all races and ethnic groups are eligible for this trial; subjects will be approximately representative of the demographics of the referral base for the participating institutions

• Patient must be able to swallow capsules

• Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol

Exclusion Criteria:

• Patients with pacemakers, aneurysm clips, neurostimulators, cochlear implants, metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded

• Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are excluded

• Patients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for ≥ 3 years, are ineligible

• Patients with an active infection or serious intercurrent medical illness are ineligible

• Patients receiving any other investigational agents are excluded

• Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded

• Patients with a history of prior cranial radiation are ineligible

• Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy

• Patients with GBMs located in the following anatomical regions known to have magnetic susceptibility or poor signal will be excluded: mesial temporal lobe, orbitofrontal cortex, prefrontal cortex, medial frontal gyrus, brainstem, and cerebellum

• The maximum radiation target volume for gross tumor volume 3 (GTV3) is 65 cc (per NRG Oncology guide); patient may be excluded after the first sMRI scan if the GTV3 volume is greater than 65 cc (we anticipate that contrast-enhancing tumor volume [residual tumor volume following tumor resection] would be less than 20 cc)