Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003015
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma
Sponsor:
Societe Internationale dOncologie Pediatrique
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Ultimate Low Grade Glioma Study
Status:
UNKNOWN
Status Verified Date:
2001-01
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 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 Randomized phase III trial to compare the effectiveness of carboplatin plus vincristine in treating children and adolescents with low grade glioma
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin plus vincristine in treating children and adolescents with low grade glioma
Detailed Description:
OBJECTIVES I Develop a standardized scheme of therapy for children and adolescents with low grade glioma II Determine the effectiveness of carboplatin and vincristine in treating children aged less than 5 years with severe or progressive symptoms or unequivocal imaging evidence of tumor growth
OUTLINE A complete resection of tumor is performed on patients with low grade glioma with or without neurofibromatosis type 1 Surgery is reconsidered following tumor relapse progression or clinical deterioration Every effort is made to obtain a biopsy from patients not receiving debulking surgery Nonoperative patients and postoperative patients who are not candidates for second surgery receive chemotherapy or radiotherapy Postoperative patients receive radiotherapy following surgical wound healing and within 28 days of resection Children less than 5 years old receive chemotherapy first then radiotherapy if the tumor subsequently progresses or recurs All other patients receive radiotherapy then chemotherapy The latter treatment is conducted in the presence of tumor progression Chemotherapy is given in 2 parts first an initial intensive phase phase 1 then a later continuation phase phase 2 In phase 1 patients receive vincristine IV weekly for 10 weeks and carboplatin IV every 3 weeks In phase 2 patients receive vincristine IV and carboplatin IV every 4 weeks for a total treatment time of 52 weeks Chemotherapy continues until disease progression or unacceptable toxicity Patients receive radiotherapy daily 5 times a week Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study over 5 years
OUTLINE A complete resection of tumor is performed on patients with low grade glioma with or without neurofibromatosis type 1 Surgery is reconsidered following tumor relapse progression or clinical deterioration Every effort is made to obtain a biopsy from patients not receiving debulking surgery Nonoperative patients and postoperative patients who are not candidates for second surgery receive chemotherapy or radiotherapy Postoperative patients receive radiotherapy following surgical wound healing and within 28 days of resection Children less than 5 years old receive chemotherapy first then radiotherapy if the tumor subsequently progresses or recurs All other patients receive radiotherapy then chemotherapy The latter treatment is conducted in the presence of tumor progression Chemotherapy is given in 2 parts first an initial intensive phase phase 1 then a later continuation phase phase 2 In phase 1 patients receive vincristine IV weekly for 10 weeks and carboplatin IV every 3 weeks In phase 2 patients receive vincristine IV and carboplatin IV every 4 weeks for a total treatment time of 52 weeks Chemotherapy continues until disease progression or unacceptable toxicity Patients receive radiotherapy daily 5 times a week Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study over 5 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 |
|---|---|---|---|
| EU-96063 | None | None | None |
| SIOP-95-2 | None | None | None |