Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031577
Status:
TERMINATED
Last Update Posted:
2015-03-19
First Post:
2002-03-08
Brief Title:
Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative closure 9222006 Decline in enrollment at CHOP due to competing protocols with new agents
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 Radiation therapy uses high-energy x-rays to damage tumor cells Paclitaxel may make the tumor cells more sensitive to radiation therapy
PURPOSE Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma
PURPOSE Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of paclitaxel when combined with involved-field radiotherapy in children with newly diagnosed diffuse intrinsic brain stem glioma
Determine the toxicity of this regimen in these patients
Assess the antitumor activity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of paclitaxel
Patients receive induction therapy comprising paclitaxel intravenously IV over 1 hour once weekly and involved-field radiotherapy after paclitaxel infusion once daily 5 days a week for 6 weeks
Beginning 6 weeks after completion of induction therapy patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A minimum of 12 patients will be accrued for this study within 12-18 months
Determine the maximum tolerated dose of paclitaxel when combined with involved-field radiotherapy in children with newly diagnosed diffuse intrinsic brain stem glioma
Determine the toxicity of this regimen in these patients
Assess the antitumor activity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of paclitaxel
Patients receive induction therapy comprising paclitaxel intravenously IV over 1 hour once weekly and involved-field radiotherapy after paclitaxel infusion once daily 5 days a week for 6 weeks
Beginning 6 weeks after completion of induction therapy patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A minimum of 12 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| CDR0000069064 | None | None | None |
| CHP-623 | None | None | None |
| BMS-CHP-623 | None | None | None |
| NCI-V01-1677 | None | None | None |