Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095771
Status:
COMPLETED
Last Update Posted:
2011-04-22
First Post:
2004-11-09
Brief Title:
Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase I trial to study the effectiveness of combining arsenic trioxide with radiation therapy in treating patients who have newly diagnosed gliomas
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-J0423 | None | None | None |
| JHOC-04041906 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |