Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Dose Escalating Study of the Safety and Tolerability of Gadolinium Texaphyrin as a Radiation Sensitizer in Patients With Primary Glioblastoma Multiforme
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin
gadolinium may increase the effectiveness of radiation therapy by making tumor cells more
sensitive to radiation.
PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation
therapy in treating patients who have newly diagnosed glioblastoma multiforme.
OBJECTIVES: I. Determine the safety and tolerability of motexafin gadolinium in combination
with radiotherapy in patients with newly diagnosed glioblastoma multiforme. II. Determine
the intratumoral pharmacology and quantitative pharmacokinetics of this drug in this patient
population.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium. Patients
receive a loading dose regimen comprising motexafin gadolinium IV over 10-15 minutes on days
1-5 or days 1-5 and 8-12 (cohort 7). After the loading dose regimen, patients receive a
maintenance regimen comprising motexafin gadolinium IV 3 times weekly for a maximum of 6.5
weeks. Patients also undergo radiotherapy once daily, 5 days a week, for 6.5 weeks. Cohorts
of 3-6 patients receive an escalating number of doses of motexafin gadolinium until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks
and then every 3 months thereafter.
PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study.
;
Primary Purpose: Treatment
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