Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083096
Status:
UNKNOWN
Last Update Posted:
2015-02-10
First Post:
2004-05-14
Brief Title:
Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I Study Of SCH66336 Lonafarnib A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas
Status:
UNKNOWN
Status Verified Date:
2015-02
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 Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die Giving lonafarnib together with temozolomide may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of lonafarnib when given together with temozolomide in treating patients with recurrent primary supratentorial glioma
PURPOSE This phase I trial is studying the side effects and best dose of lonafarnib when given together with temozolomide in treating patients with recurrent primary supratentorial glioma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of lonafarnib when administered with temozolomide in patients with recurrent primary supratentorial gliomas
Determine the safety and tolerability of this regimen in these patients
Secondary
Determine the mechanism of action of lonafarnib in these patients
Determine the pharmacodynamics and pharmacokinetics of this regimen in these patients
Determine the activity of this regimen in these patients
Determine the response to this regimen in patients who have measurable disease
OUTLINE This is a nonrandomized multicenter open-label dose-escalation study of lonafarnib
Patients receive oral temozolomide once daily on days 2-6 of course 1 and on days 1-5 of all subsequent courses Patients also receive oral lonafarnib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of lonafarnib until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experience dose-limiting toxicity An additional 3 patients may be treated at the highest dose level achieved
Patients are followed every 8 weeks for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of lonafarnib when administered with temozolomide in patients with recurrent primary supratentorial gliomas
Determine the safety and tolerability of this regimen in these patients
Secondary
Determine the mechanism of action of lonafarnib in these patients
Determine the pharmacodynamics and pharmacokinetics of this regimen in these patients
Determine the activity of this regimen in these patients
Determine the response to this regimen in patients who have measurable disease
OUTLINE This is a nonrandomized multicenter open-label dose-escalation study of lonafarnib
Patients receive oral temozolomide once daily on days 2-6 of course 1 and on days 1-5 of all subsequent courses Patients also receive oral lonafarnib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of lonafarnib until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experience dose-limiting toxicity An additional 3 patients may be treated at the highest dose level achieved
Patients are followed every 8 weeks for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
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 |
|---|---|---|---|
| SPRI-P03174 | None | None | None |
| EORTC-16027 | None | None | None |
| EORTC-26023 | None | None | None |