A Phase I Dose Escalating Study of the Safety and Tolerability of Gadolinium Texaphyrin as a Radiation Sensitizer in Patients With Primary 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.
Interventional
Primary Purpose: Treatment
Judith M. Ford, MD, PhD
Study Chair
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000066421
NCT00003409
July 1998
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of California Davis Cancer Center | Sacramento, California 95817 |