Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045565
Status:
COMPLETED
Last Update Posted:
2013-04-09
First Post:
2002-09-06
Brief Title:
Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2013-04
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:
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
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
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 |
|---|---|---|---|
| U01CA062475 | NIH | None | httpsreporternihgovquickSearchU01CA062475 |
| NABTT-2115 | None | None | None |
| JHOC-NABTT-2115 | None | None | None |