Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022724
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2001-08-10
Brief Title:
CCI-779 in Treating Patients With Malignant Glioma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase III Trial Of CCI-779 In Patients With Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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
PURPOSE Phase III trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma
PURPOSE Phase III trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma
Determine the safety profile of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the efficacy of this drug in terms of survival and objective response in these patients
OUTLINE This is a dose-escalation study Patients in phase II are stratified according to use of enzyme-inducing antiepileptic drugs EIAEDs yes vs no and disease type glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant glioma Patients in phase I must be currently receiving EIAEDs
Phase I Patients receive CCI-779 IV over 30 minutes once weekly Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CCI-779 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
Phase II Patients receive CCI-779 as in Phase I Patients who are candidates for surgical resection of recurrent disease receive CCI-779 IV over 30 minutes 2 hours prior to surgery and then once weekly as above once recovered from surgery
Patients are followed for survival
PROJECTED ACCRUAL A total of 36 patients will be accrued for phase I of this study within 12 months A total of 87 patients will be accrued for phase II of this study within 12 months
Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma
Determine the safety profile of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the efficacy of this drug in terms of survival and objective response in these patients
OUTLINE This is a dose-escalation study Patients in phase II are stratified according to use of enzyme-inducing antiepileptic drugs EIAEDs yes vs no and disease type glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant glioma Patients in phase I must be currently receiving EIAEDs
Phase I Patients receive CCI-779 IV over 30 minutes once weekly Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CCI-779 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
Phase II Patients receive CCI-779 as in Phase I Patients who are candidates for surgical resection of recurrent disease receive CCI-779 IV over 30 minutes 2 hours prior to surgery and then once weekly as above once recovered from surgery
Patients are followed for survival
PROJECTED ACCRUAL A total of 36 patients will be accrued for phase I of this study within 12 months A total of 87 patients will be accrued for phase II of this study within 12 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 |
|---|---|---|---|
| CDR0000068848 | REGISTRY | PDQ Physician Data Query | None |