Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027612
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2001-12-07
Brief Title:
Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Pilot And Phase II Trial Of Irinotecan And Radiation Followed By Irinotecan And BCNU In Glioblastoma Multiforme Patients
Status:
COMPLETED
Status Verified Date:
2016-12
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 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 Irinotecan may make the tumor cells more sensitive to radiation therapy
PURPOSE This phase III trial is studying the side effects of irinotecan given together with radiation therapy followed by irinotecan and carmustine and to see how well it works in treating patients with newly-diagnosed glioblastoma multiforme
PURPOSE This phase III trial is studying the side effects of irinotecan given together with radiation therapy followed by irinotecan and carmustine and to see how well it works in treating patients with newly-diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the safety of adjuvant irinotecan when administered concurrently with radiotherapy in patients with newly diagnosed glioblastoma multiforme
Determine survival of patients treated with this regimen followed by irinotecan and carmustine
Assess the toxic effects of this regimen in these patients
Determine whether the dose of irinotecan chosen produces radiosensitizing plasma concentrations of SN-38 in these patients
Assess individual variation in responses toxicity andor activity pharmacokinetic parameters andor biological correlates due to genetic differences in enzymes involved in transport metabolism andor mechanism of action of irinotecan in these patients treated with this regimen
OUTLINE This is a pilot dose-escalation study of irinotecan Patients are stratified according to receipt of concurrent enzyme-inducing anticonvulsants EIACs yes vs no
Phase I closed to accrual as of 352005 Patients receive carmustine IV over 2 hours on day 1 of courses 2-5 and irinotecan IV over 90 minutes beginning immediately after carmustine infusion on days 1 8 22 and 29 of courses 1-5 Patients also undergo radiotherapy 5 days a week for 6 weeks concurrently with course 1 only Treatment repeats every 6 weeks for 5 courses in the absence of unacceptable toxicity
Cohorts of 6 patients receive escalating doses of irinotecan until the recommended dose for phase II is determined The recommended dose for phase II is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity
Determine the safety of adjuvant irinotecan when administered concurrently with radiotherapy in patients with newly diagnosed glioblastoma multiforme
Determine survival of patients treated with this regimen followed by irinotecan and carmustine
Assess the toxic effects of this regimen in these patients
Determine whether the dose of irinotecan chosen produces radiosensitizing plasma concentrations of SN-38 in these patients
Assess individual variation in responses toxicity andor activity pharmacokinetic parameters andor biological correlates due to genetic differences in enzymes involved in transport metabolism andor mechanism of action of irinotecan in these patients treated with this regimen
OUTLINE This is a pilot dose-escalation study of irinotecan Patients are stratified according to receipt of concurrent enzyme-inducing anticonvulsants EIACs yes vs no
Phase I closed to accrual as of 352005 Patients receive carmustine IV over 2 hours on day 1 of courses 2-5 and irinotecan IV over 90 minutes beginning immediately after carmustine infusion on days 1 8 22 and 29 of courses 1-5 Patients also undergo radiotherapy 5 days a week for 6 weeks concurrently with course 1 only Treatment repeats every 6 weeks for 5 courses in the absence of unacceptable toxicity
Cohorts of 6 patients receive escalating doses of irinotecan until the recommended dose for phase II is determined The recommended dose for phase II is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| U10CA025224 | NIH | CTRP Clinical Trials Reporting System | httpsreporternihgovquickSearchU10CA025224 |
| NCCTG-N997D | None | None | None |
| CDR0000069048 | REGISTRY | None | None |
| NCI-2012-02428 | REGISTRY | None | None |