Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005955
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2000-07-05
Brief Title:
Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2009-10
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 use 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 Chemotherapy combined with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors
PURPOSE Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors
Detailed Description:
OBJECTIVES
Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors
Determine the toxicity of this treatment in these patients
Determine the overall survival in these patients for 18 months following the study after receiving this treatment
OUTLINE Patients are stratified according to type of disease ependymoma vs brain stem glioma vs malignant glioma vs other
Patients receive oral temozolomide on days 1-5 Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy
PROJECTED ACCRUAL A maximum of 100 patients 25 per stratum will be accrued for this study over 24-36 months
Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors
Determine the toxicity of this treatment in these patients
Determine the overall survival in these patients for 18 months following the study after receiving this treatment
OUTLINE Patients are stratified according to type of disease ependymoma vs brain stem glioma vs malignant glioma vs other
Patients receive oral temozolomide on days 1-5 Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy
PROJECTED ACCRUAL A maximum of 100 patients 25 per stratum will be accrued for this study over 24-36 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 |
|---|---|---|---|
| CDR0000067936 | OTHER | NCI | None |
| DUMC-0931-02-6R3 | None | None | None |
| DUMC-000931-00-5R1 | None | None | None |
| DUMC-0831-99-5 | None | None | None |
| NCI-G00-1799 | None | None | None |
| DUMC-000931-01-6R1 | None | None | None |