Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002944
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Progressive Brain Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old
Status:
COMPLETED
Status Verified Date:
2013-09
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 Combining more than one drug may kill more tumor cells
PURPOSE This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain
PURPOSE This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain
Detailed Description:
OBJECTIVES
Compare the event free survival as a result of treatment with carboplatin and vincristine versus thioguanine procarbazine lomustine and vincristine in children with progressive brain tumors
Estimate tumor response rates to each regimen of chemotherapy in these patients
Determine toxic effects and quality of life of children treated with each regimen of chemotherapy
Investigate biological and clinical factors which may predict tumor response and early progression tumor size location pathologic subtype cytogenetics and proliferative index by MIB-1 Ki67 in these patients
Investigate factors contributing to neuropsychological and endocrine status of children with brain tumors treated without irradiation
OUTLINE This is a randomized study Patients are stratified according to site of disease status at entry and pathology Patients are randomized to one of two treatment arms Patients with neurofibromatosis are nonrandomly assigned to arm II
Arm I Patients receive induction with carboplatin and vincristine for 10 weeks followed by 2 weeks of rest Induction is followed by 8 courses of maintenance beginning on day 84 of induction or upon hematopoietic recovery Each course consists of 4 weekly doses of carboplatin and 3 weekly doses of vincristine given concurrently with the first 3 weeks of carboplatin followed by 2 weeks of rest
Arm II Patients receive oral thioguanine procarbazine and lomustine on days 0-4 followed by vincristine IV on days 14 and 28 Treatment continues every 6 weeks for a maximum of 8 courses
PROJECTED ACCRUAL A total of 280-340 patients will be accrued over 4 years
Compare the event free survival as a result of treatment with carboplatin and vincristine versus thioguanine procarbazine lomustine and vincristine in children with progressive brain tumors
Estimate tumor response rates to each regimen of chemotherapy in these patients
Determine toxic effects and quality of life of children treated with each regimen of chemotherapy
Investigate biological and clinical factors which may predict tumor response and early progression tumor size location pathologic subtype cytogenetics and proliferative index by MIB-1 Ki67 in these patients
Investigate factors contributing to neuropsychological and endocrine status of children with brain tumors treated without irradiation
OUTLINE This is a randomized study Patients are stratified according to site of disease status at entry and pathology Patients are randomized to one of two treatment arms Patients with neurofibromatosis are nonrandomly assigned to arm II
Arm I Patients receive induction with carboplatin and vincristine for 10 weeks followed by 2 weeks of rest Induction is followed by 8 courses of maintenance beginning on day 84 of induction or upon hematopoietic recovery Each course consists of 4 weekly doses of carboplatin and 3 weekly doses of vincristine given concurrently with the first 3 weeks of carboplatin followed by 2 weeks of rest
Arm II Patients receive oral thioguanine procarbazine and lomustine on days 0-4 followed by vincristine IV on days 14 and 28 Treatment continues every 6 weeks for a maximum of 8 courses
PROJECTED ACCRUAL A total of 280-340 patients will be accrued over 4 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 |
|---|---|---|---|
| CDR0000065394 | OTHER | Clinical Trialsgov | None |
| CCG-A9952 | OTHER | None | None |
| POG-A9952 | OTHER | None | None |
| CCG-9952 | OTHER | None | None |