Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360854
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-08-03
Brief Title:
Erlotinib Alone or in Combination With Radiation Therapy in Treating Young Patients With Refractory or Relapsed Malignant Brain Tumors or Newly Diagnosed Brain Stem Glioma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Studies of TARCEVA ERLOTINIB HYDROCHLORIDE OSI-774 as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma
Status:
UNKNOWN
Status Verified Date:
2007-06
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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Radiation therapy uses high-energy x-rays to kill tumor cells Giving erlotinib together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of erlotinib when given alone or together with radiation therapy in treating young patients with refractory or relapsed malignant brain tumors or newly diagnosed brain stem glioma
PURPOSE This phase I trial is studying the side effects and best dose of erlotinib when given alone or together with radiation therapy in treating young patients with refractory or relapsed malignant brain tumors or newly diagnosed brain stem glioma
Detailed Description:
OBJECTIVES
Primary
Establish the maximum tolerated dose of single-agent erlotinib hydrochloride in pediatric patients with refractory or relapsed malignant brain tumors and in combination with radiotherapy in pediatric patients with newly diagnosed brain stem glioma
Secondary
Determine dose-limiting toxicities of these regimens
Define the safety profile of these regimens
Characterize the pharmacokinetic behavior of erlotinib hydrochloride in these patients
Evaluate the efficacy of these regimens
Correlate expression and mutations of epidermal growth factor receptor with treatment response
OUTLINE This is a multicenter nonrandomized open-label dose-escalation study of erlotinib hydrochloride Patients are assigned to 1 of 2 treatment groups according to disease
Group 1 refractory or relapsed malignant brain tumors Patients receive oral erlotinib hydrochloride once daily on days 1-21 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride 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 DLT
Group 2 newly diagnosed brain stem glioma Patients receive oral erlotinib hydrochloride once daily on days 1-21 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression Beginning on day 1 patients also undergo radiotherapy 5 days a week for 6 weeks
Cohorts of 1-2 patients receive escalating doses of erlotinib hydrochloride until the MTD is determined The MTD is defined as the dose resulting in 25 of patients experiencing DLT at 6 weeks
Blood is collected for pharmacokinetic assessments and pharmacogenetic genotyping for analysis of enzyme polymorphisms Tumor tissue may be assessed for epidermal growth factor receptor mutations
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study
Primary
Establish the maximum tolerated dose of single-agent erlotinib hydrochloride in pediatric patients with refractory or relapsed malignant brain tumors and in combination with radiotherapy in pediatric patients with newly diagnosed brain stem glioma
Secondary
Determine dose-limiting toxicities of these regimens
Define the safety profile of these regimens
Characterize the pharmacokinetic behavior of erlotinib hydrochloride in these patients
Evaluate the efficacy of these regimens
Correlate expression and mutations of epidermal growth factor receptor with treatment response
OUTLINE This is a multicenter nonrandomized open-label dose-escalation study of erlotinib hydrochloride Patients are assigned to 1 of 2 treatment groups according to disease
Group 1 refractory or relapsed malignant brain tumors Patients receive oral erlotinib hydrochloride once daily on days 1-21 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride 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 DLT
Group 2 newly diagnosed brain stem glioma Patients receive oral erlotinib hydrochloride once daily on days 1-21 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression Beginning on day 1 patients also undergo radiotherapy 5 days a week for 6 weeks
Cohorts of 1-2 patients receive escalating doses of erlotinib hydrochloride until the MTD is determined The MTD is defined as the dose resulting in 25 of patients experiencing DLT at 6 weeks
Blood is collected for pharmacokinetic assessments and pharmacogenetic genotyping for analysis of enzyme polymorphisms Tumor tissue may be assessed for epidermal growth factor receptor mutations
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2004-005247-10 | None | None | None |
| CCLG-NAG-2005-09 | None | None | None |
| ITCC-003 | None | None | None |
| EU-20617 | None | None | None |
| CCLG-CPP-05-07 | None | None | None |
| ROCHE-MO18461 | None | None | None |