Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100802
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2005-01-06
Brief Title:
Radiation Therapy Temozolomide and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma
Status:
COMPLETED
Status Verified Date:
2023-01
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 II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas Radiation therapy uses high energy x-rays to kill tumor cells Drugs used in chemotherapy such as temozolomide and lomustine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomustine with historical controls
II Determine the toxicity of this regimen in these patients III Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with this regimen
IV Correlate polymorphisms in GSTP1 GSTM1 and GSTT1 genes and GSTP1 protein expression in tumors with survival in patients treated with this regimen
OUTLINE This is a pilot multicenter study
CHEMORADIOTHERAPY Patients receive oral temozolomide once daily on days 1-42 Patients also undergo concurrent radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-40 Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47
MAINTENANCE CHEMOTHERAPY Four weeks after completion of chemoradiotherapy patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1 Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
I Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomustine with historical controls
II Determine the toxicity of this regimen in these patients III Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with this regimen
IV Correlate polymorphisms in GSTP1 GSTM1 and GSTT1 genes and GSTP1 protein expression in tumors with survival in patients treated with this regimen
OUTLINE This is a pilot multicenter study
CHEMORADIOTHERAPY Patients receive oral temozolomide once daily on days 1-42 Patients also undergo concurrent radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-40 Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47
MAINTENANCE CHEMOTHERAPY Four weeks after completion of chemoradiotherapy patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1 Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually 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 |
|---|---|---|---|
| NCI-2012-02645 | REGISTRY | None | None |
| ACNS0423 | None | None | None |
| CDR0000407744 | None | None | None |
| COG-ACNS0423 | None | None | None |
| ACNS0423 | OTHER | None | None |
| ACNS0423 | OTHER | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |