Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281905
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-01-24
Brief Title:
Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Management of Children Aged Less Than 3 Years With Brain Tumors
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays to kill tumor cells Giving radiation therapy after chemotherapy may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors
Detailed Description:
OBJECTIVES
Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine methotrexate carboplatin cyclophosphamide and cisplatin with or without radiotherapy
Determine the event-free survival and overall survival in children treated with this regimen
Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen
Determine the quality of life in children treated with this regimen
Determine the tolerability and long-term toxicity of this regimen in these children
Determine the proportion of children who require radiotherapy after treatment with this regimen
Determine the prognosis of children who receive both chemotherapy and radiotherapy
Determine the nature and behavior of brain tumors in very young children
OUTLINE This is a multicenter study
Chemotherapy Patients receive vincristine IV on days 0 14 and 28 carboplatin IV over 4 hours on day 0 methotrexate IV continuously over 24 hours on day 14 cyclophosphamide IV over 4 hours on day 28 and cisplatin IV continuously over 48 hours on days 42 and 43 Courses repeat every 56 days 8 weeks for up to 12 months Patients who achieve a complete response proceed to observation as do those achieving a partial response with no tumor present on biopsy Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that dont have the potential to spread through the cerebrospinal fluid CSF proceed to local radiotherapy Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy
Local radiotherapy Patients undergo local radiotherapy 5 days a week for 5-5½ weeks
Craniospinal radiotherapy Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks
Quality of life is assessed periodically
After completion of study treatment patients are followed periodically for at least 2 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine methotrexate carboplatin cyclophosphamide and cisplatin with or without radiotherapy
Determine the event-free survival and overall survival in children treated with this regimen
Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen
Determine the quality of life in children treated with this regimen
Determine the tolerability and long-term toxicity of this regimen in these children
Determine the proportion of children who require radiotherapy after treatment with this regimen
Determine the prognosis of children who receive both chemotherapy and radiotherapy
Determine the nature and behavior of brain tumors in very young children
OUTLINE This is a multicenter study
Chemotherapy Patients receive vincristine IV on days 0 14 and 28 carboplatin IV over 4 hours on day 0 methotrexate IV continuously over 24 hours on day 14 cyclophosphamide IV over 4 hours on day 28 and cisplatin IV continuously over 48 hours on days 42 and 43 Courses repeat every 56 days 8 weeks for up to 12 months Patients who achieve a complete response proceed to observation as do those achieving a partial response with no tumor present on biopsy Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that dont have the potential to spread through the cerebrospinal fluid CSF proceed to local radiotherapy Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy
Local radiotherapy Patients undergo local radiotherapy 5 days a week for 5-5½ weeks
Craniospinal radiotherapy Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks
Quality of life is assessed periodically
After completion of study treatment patients are followed periodically for at least 2 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCLG-CNS-1992-04 | None | None | None |
| CCLG-CNS-9204 | None | None | None |
| EU-20574 | None | None | None |