NCT00003409

Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase I Dose Escalating Study of the Safety and Tolerability of Gadolinium Texaphyrin as a Radiation Sensitizer in Patients With Primary Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	motexafin gadolinium
RADIATION	radiation therapy

Timeline

• Start date: 1998-07-01
• First posted: 2003-12-02
• Last updated: 2009-02-09

Locations

2 sites across 1 country: United States