Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas
| Status: | Archived |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to
stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
high-energy x-rays to damage tumor cells and may be an effective treatment for patients with
glioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive to
radiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide with
radiation therapy in treating patients who have newly diagnosed gliomas.
OBJECTIVES:
- Determine the maximum tolerated dose of arsenic trioxide when administered with
radiotherapy in pediatric patients with newly diagnosed anaplastic astrocytoma,
glioblastoma multiforme, gliosarcoma, or intrinsic pontine glioma.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of arsenic trioxide (ATO).
Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks. Patients
concurrently receive ATO IV over 1 hour, 1-5 times weekly, for approximately 6 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ATO until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 3-36
months.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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