Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352495
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2006-07-13
Brief Title:
Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2014-02
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 vinblastine and carboplatin 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
PURPOSE This phase I trial is studying the side effects and best dose of vinblastine when given together with carboplatin in treating young patients with newly diagnosed or recurrent low-grade glioma
PURPOSE This phase I trial is studying the side effects and best dose of vinblastine when given together with carboplatin in treating young patients with newly diagnosed or recurrent low-grade glioma
Detailed Description:
OBJECTIVES
Primary
Estimate the maximum tolerated dose and recommended phase II dose of vinblastine when given in combination with carboplatin in pediatric patients with newly diagnosed or recurrent low-grade gliomas
Define and describe the acute and dose-limiting toxicities of this regimen
Describe the toxicities associated with repeated courses of the combination chemotherapy regimen and the number of treatment modifications required over the course of treatment
Secondary
Describe the radiographic responses in patients treated with this regimen
Describe changes in diffusionperfusion imaging during study therapy
OUTLINE This is a multicenter dose-escalation study of vinblastine Patients are stratified according to amount of prior therapy heavily pretreated vs less heavily pretreated
Patients receive carboplatin IV over 30 minutes on day 1 and vinblastine IV on days 1 8 15 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vinblastine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed for 30 days
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Primary
Estimate the maximum tolerated dose and recommended phase II dose of vinblastine when given in combination with carboplatin in pediatric patients with newly diagnosed or recurrent low-grade gliomas
Define and describe the acute and dose-limiting toxicities of this regimen
Describe the toxicities associated with repeated courses of the combination chemotherapy regimen and the number of treatment modifications required over the course of treatment
Secondary
Describe the radiographic responses in patients treated with this regimen
Describe changes in diffusionperfusion imaging during study therapy
OUTLINE This is a multicenter dose-escalation study of vinblastine Patients are stratified according to amount of prior therapy heavily pretreated vs less heavily pretreated
Patients receive carboplatin IV over 30 minutes on day 1 and vinblastine IV on days 1 8 15 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vinblastine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed for 30 days
PROJECTED ACCRUAL A total of 18 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 |
|---|---|---|---|
| CDR0000483184 | None | None | None |
| COG-ADVL0515 | None | None | None |