NCT00045565

Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of arsenic trioxide and radiation therapy in treating patients with newly diagnosed malignant glioma. Drugs such as arsenic trioxide may stop the growth of malignant glioma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining arsenic trioxide with radiation therapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of Arsenic Trioxide (ATO) when administered on a once a week schedule and a twice a week schedule in conjunction with radiation therapy to patients with newly diagnosed glioblastoma multiforme. II. To determine the toxicity of ATO when it is administered on a once a week schedule and a twice a week schedule in conjunction with radiation therapy in patients with newly diagnosed glioblastoma multiforme. SECONDARY OBJECTIVES: I. To determine the survival of patients with newly diagnosed glioblastoma multiforme receiving ATO when it is administered on a once a week schedule and a twice a week schedule in conjunction with radiation therapy. II. To evaluate the effect of ATO on tumor vasculature by using perfusion MRI. III. To describe the pharmacokinetics of ATO following weekly and twice weekly injection. OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of arsenic trioxide. Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive arsenic trioxide IV over 2 hours once weekly for 6 weeks. Group B: Patients receive arsenic trioxide at a lower dose IV over 2 hours twice weekly for 6 weeks. Patients in both groups also undergo radiotherapy once daily 5 days a week for 6 weeks. In both groups, cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 4 weeks and then every 2 months thereafter.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma

Interventions

Type	Name	Description
DRUG	arsenic trioxide	Given IV
RADIATION	radiation therapy	Undergo radiation therapy

Timeline

• Start date: 2002-10-01
• Primary completion: 2008-11-01
• First posted: 2003-01-27
• Last updated: 2013-04-09

Locations

1 site across 1 country: United States