Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Glioma
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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of ATO in conjunction with radiotherapy and optimum ATO dose for radiosensitization determined by dose-limiting toxicities
Results of the safety evaluation will be tabulated and displayed by dose level.
New Approaches to Brain Tumor Therapy Consortium
United States: Food and Drug Administration
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