Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025675
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2001-10-11
Brief Title:
Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
ZD1839 FOR Treatment Of Recurrent Or Progressive Malignant Astrocytoma Or Glioblastoma And Recurrent Or Progressive Meningioma A Phase II Study With A Phase I Component For Patients Receiving EIAEDs
Status:
COMPLETED
Status Verified Date:
2018-06
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 Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of CNS tumors
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or progressive CNS tumors
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or progressive CNS tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of gefitinib in patients with recurrent or progressive supratentorial malignant gliomas or brain or spinal meningiomas receiving enzyme-inducing antiepileptic drugs EIAEDs Phase I of the study closed to accrual as of 09192003
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in patients receiving EIAEDs
Determine the efficacy of this drug in terms of 6-month progression-free survival of these patients
Determine the safety profile of the phase II dose of this drug in these patients
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs EIAEDs yes vs no and disease type for phase II only benign meningioma vs malignant meningioma vs hemangiopericytoma vs glioblastoma vs other anaplastic glioma Phase I closed to accrual as of 09192003
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients who are receiving EIAEDs receive escalating doses of gefitinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 2 weeks
PROJECTED ACCRUAL A minimum of 30 patients will be accrued for the phase I portion of this study within 10 months Phase I closed to accrual as of 09192003 A total of 48 patients will be accrued for the phase II portion of this study within 6-8 months
Determine the maximum tolerated dose of gefitinib in patients with recurrent or progressive supratentorial malignant gliomas or brain or spinal meningiomas receiving enzyme-inducing antiepileptic drugs EIAEDs Phase I of the study closed to accrual as of 09192003
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in patients receiving EIAEDs
Determine the efficacy of this drug in terms of 6-month progression-free survival of these patients
Determine the safety profile of the phase II dose of this drug in these patients
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs EIAEDs yes vs no and disease type for phase II only benign meningioma vs malignant meningioma vs hemangiopericytoma vs glioblastoma vs other anaplastic glioma Phase I closed to accrual as of 09192003
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients who are receiving EIAEDs receive escalating doses of gefitinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 2 weeks
PROJECTED ACCRUAL A minimum of 30 patients will be accrued for the phase I portion of this study within 10 months Phase I closed to accrual as of 09192003 A total of 48 patients will be accrued for the phase II portion of this study within 6-8 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 |
|---|---|---|---|
| NABTC-0001 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062399 |
| U01CA062399 | NIH | None | None |
| ABTC-0001 | None | None | None |