Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102648
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-01-03
First Post:
2005-01-31
Brief Title:
Lonafarnib and Temozolomide in Treating Patients with Glioblastoma Multiforme That is Recurrent or Did Not Respond to Previous Treatment with Temozolomide
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase IIb Study of Sarasar and Temodar in Patients with Recurrent or Temodar-Refractory Glioblastoma Multiforme
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
This phase I trial studies the side effects and best dose of lonafarnib when given together with temozolomide and to see how well they work in treating patients with glioblastoma multiforme that is has come back or did not respond to previous treatment with temozolomide Lonafarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving lonafarnib together with temozolomide may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose Sarasar SCH66336 lonafarnib when combined with Temodar temozolomide in an alternating week schedule
II To describe the toxicities of the Sarasar and Temodar combination treatment using this dosing schedule
III To evaluate response as measured by 6-month progression-free survival and objective tumor response
OUTLINE This is a dose-escalation study of lonafarnib
Patients receive temozolomide orally PO once daily QD on days 1-7 and 15-21 and lonafarnib PO twice daily BID on days 8-14 and 22-28 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months
I To determine the maximum tolerated dose Sarasar SCH66336 lonafarnib when combined with Temodar temozolomide in an alternating week schedule
II To describe the toxicities of the Sarasar and Temodar combination treatment using this dosing schedule
III To evaluate response as measured by 6-month progression-free survival and objective tumor response
OUTLINE This is a dose-escalation study of lonafarnib
Patients receive temozolomide orally PO once daily QD on days 1-7 and 15-21 and lonafarnib PO twice daily BID on days 8-14 and 22-28 Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2004-0424 | OTHER | M D Anderson Cancer Center | None |
| NCI-2012-01311 | REGISTRY | None | None |
| NCI-2010-00417 | None | None | None |