Brain and Central Nervous System Tumors Clinical Trial
Official title:
Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas
RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may
improve the ability to detect the extent of gliomas.
PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with
MRI-guided surgery in treating patients with high-grade glioma.
OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin as a tumor
retained contrast agent in MRI guided neurosurgery in patients with radiological diagnosis
of high grade glioma. I. Determine the intratumoral pharmacology and quantitative
pharmacokinetics of gadolinium texaphyrin using MRI imaging in these patients. II. Develop a
scale that will relate MRI signal characteristics from intratumoral gadolinium texaphyrin
with absolute intratumoral levels of gadolinium texaphyrin in these patients. III.
Investigate the distribution of gadolinium texaphyrin in high grade gliomas in comparison
with biologically active tumor as delineated by elevated choline-containing material
detected by proton magnetic resonance spectroscopic imaging.
OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin by IV
infusion 20 minutes to 2 hours prior to magnetic resonance imaging and surgery. The maximum
tolerated dose for a single dose of gadolinium texaphyrin is determined by cohorts of 3
patients who are treated at one of five escalating doses. Patients in each cohort are
followed for a minimum of 4 weeks each before the next cohort begins. If good contrast
enhancement is assessed at the fourth dose level (cohort 4), dose escalation stops. Patients
are followed at days 1 and 2, at weeks 1, 2, and 4, and at 3 months after surgery.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued into this study.
;
Primary Purpose: Diagnostic
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