Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003935
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of Children With Diffuse Intrinsic Brain Stem Glioma With Standard Dose Irradiation and Vincristine Plus Oral VP-16 A POG Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-07
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 Combining more than one drug with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma
PURPOSE Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma
Detailed Description:
OBJECTIVES I Evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma II Assess the toxicity of this regimen in this patient population
OUTLINE Induction Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1 8 and 15 Treatment repeats every 4 weeks for 2 courses Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy Maintenance One week after induction therapy patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21 Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2 years
OUTLINE Induction Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1 8 and 15 Treatment repeats every 4 weeks for 2 courses Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy Maintenance One week after induction therapy patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21 Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| COG-P9836 | OTHER | Childrens Oncology Group | None |
| POG-9836 | OTHER | None | None |
| CDR0000067127 | OTHER | None | None |