Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003203
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
1999-11-01
Brief Title:
Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
An Intergroup Pilot Study of Concurrent Carboplatin Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors
Status:
COMPLETED
Status Verified Date:
2013-08
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 such as carboplatin and vincristine work in 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 carboplatin and vincristine with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors
Detailed Description:
OBJECTIVES
Determine the feasible dose and duration of carboplatin combined with craniospinal and local radiotherapy and adjuvant chemotherapy in children with newly diagnosed high-risk CNS embryonal tumors Phase I completed as of 11-25-03
Determine the feasibility of administering cyclophosphamide and vincristine with or without cisplatin after concurrent carboplatin vincristine and radiotherapy in these patients
Determine the overall and individual toxicity rates of this regimen in these patients
Determine the complete response rate in patients treated with this regimen
Obtain preliminary estimates of event-free survival of patients treated with this regimen
Determine the prognostic significance of enhancing tumor after completion of radiotherapy on event-free survival of these patients
OUTLINE This is a pilot dose-escalation study of carboplatin Phase I completed as of 11-25-03
Within 31 days of definitive surgery all patients receive vincristine IV weekly for 6 weeks and carboplatin IV over 15-20 minutes after completion of vincristine infusion 5 days a week for 6 weeks Patients undergo radiotherapy 1-4 hours after carboplatin infusion 5 days a week for 6 weeks
Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 3 of 12 patients experience dose-limiting toxicity Phase I completed as of 11-25-03
At 6 weeks after completion of radiotherapy patients are assigned to arm II for adjuvantmaintenance chemotherapy Arm I closed to accrual as of 11-25-03
Arm I closed to accrual as of 11-25-03 Patients receive cyclophosphamide IV over 1 hour on days 0 and 1 vincristine IV on days 0 and 7 and filgrastim G-CSF IV or subcutaneously SC beginning on day 2 and continuing for at least 10 days until blood counts recover
Arm II Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 vincristine IV on days 0 and 7 cisplatin IV over 6 hours on day 0 and G-CSF IV or SC beginning on day 3 and continuing for at least 10 days until blood counts recover
In both arms adjuvantmaintenance chemotherapy repeats every 4 weeks for 6 courses
Patients are followed every 3 months for 8 months every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 162 patients will be accrued for this study
Determine the feasible dose and duration of carboplatin combined with craniospinal and local radiotherapy and adjuvant chemotherapy in children with newly diagnosed high-risk CNS embryonal tumors Phase I completed as of 11-25-03
Determine the feasibility of administering cyclophosphamide and vincristine with or without cisplatin after concurrent carboplatin vincristine and radiotherapy in these patients
Determine the overall and individual toxicity rates of this regimen in these patients
Determine the complete response rate in patients treated with this regimen
Obtain preliminary estimates of event-free survival of patients treated with this regimen
Determine the prognostic significance of enhancing tumor after completion of radiotherapy on event-free survival of these patients
OUTLINE This is a pilot dose-escalation study of carboplatin Phase I completed as of 11-25-03
Within 31 days of definitive surgery all patients receive vincristine IV weekly for 6 weeks and carboplatin IV over 15-20 minutes after completion of vincristine infusion 5 days a week for 6 weeks Patients undergo radiotherapy 1-4 hours after carboplatin infusion 5 days a week for 6 weeks
Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 3 of 12 patients experience dose-limiting toxicity Phase I completed as of 11-25-03
At 6 weeks after completion of radiotherapy patients are assigned to arm II for adjuvantmaintenance chemotherapy Arm I closed to accrual as of 11-25-03
Arm I closed to accrual as of 11-25-03 Patients receive cyclophosphamide IV over 1 hour on days 0 and 1 vincristine IV on days 0 and 7 and filgrastim G-CSF IV or subcutaneously SC beginning on day 2 and continuing for at least 10 days until blood counts recover
Arm II Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 vincristine IV on days 0 and 7 cisplatin IV over 6 hours on day 0 and G-CSF IV or SC beginning on day 3 and continuing for at least 10 days until blood counts recover
In both arms adjuvantmaintenance chemotherapy repeats every 4 weeks for 6 courses
Patients are followed every 3 months for 8 months every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 162 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000066055 | OTHER | Clinical Trialsgov | None |
| COG-A9971 | OTHER | None | None |
| CCG-99701 | OTHER | None | None |