Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma

Withdrawn before enrolling · Phase 2

Conditions studied: Glioblastoma, Glioblastoma Multiforme

In brief

This clinical trial increases radiation to areas of the brain considered to be at risk for cancer. The at-risk areas are identified by a biological MRI scan. The study will look at side effects of the radiation and overall survival.

Key facts

Study ID

NCT03506139

Run by

John M. Buatti

People needed

0

Starts

2019-05-15

Expected to finish

2026-12-31

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and willingness to provide informed consent
• Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma.
• Patients must be 18 years of age or older.≥
• Karnofsky performance status ≥ 70
• Minimal life expectancy of 12 weeks.
• Maximal contiguous volume of tumor based on high b-value diffusion MRI and perfusion MRI < 1/3 volume of brain
• Patients must be treated within 6 weeks of most recent resection
• Within 21 days of radiation fraction 1, the following blood test parameters must be met:
• Hemoglobin ≥ 10 g/dL (transfusion is acceptable)
• absolute neutrophils ≥ 1500/mm3
• platelet count ≥ 100,000/mm3
• total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome)
• ALT and AST ≤ 5 x ULN
• serum creatinine ≤ 2.0 mg/dL

You may not qualify if…

• Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
• Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is >3 years.
• Evidence of CSF dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination).
• Multifocal disease (>1 lobe of involvement) of discontiguous, contrast enhancing disease as seen on conventional MRI
• Evidence of severe concurrent disease requiring treatment
• Known active malignancy as determined by treating medical and radiation oncologist
• Patients unable to undergo MRI exams
• Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring inpatient hospitalization or delay treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise subject safety.
• Pregnant women are excluded from this study because ionizing radiation is a known teratogen, and temozolomide is a Class D agent with the potential for teratogenic or abortifacient effects.
• Nursing mothers declining to discontinue breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with temozolomide.
• Patients with reproductive potential declining to use an effective contraceptive method during treatment are excluded from this study.

Where it is running

• University of Iowa Department of Radiation Oncology — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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