Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058097
Status:
COMPLETED
Last Update Posted:
2013-04-09
First Post:
2003-04-07
Brief Title:
Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Radiation therapy uses high-energy x-rays to damage tumor cells Combining tipifarnib with radiation therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To estimate overall survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before and possibly after radiation therapy
SECONDARY OBJECTIVES
I To estimate response rate in adult patients with newly diagnosed glioblastoma multiforme treated with R115777 prior to therapy with radiation
II To estimate progression free survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before and possibly after radiation therapy
III To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme
OUTLINE This is a multicenter study
INDUCTION THERAPY Patients receive oral tipifarnib twice daily for 3 weeks Treatment repeats every 4 weeks for up to 3 courses
RADIOTHERAPY Within 14 days after the completion of induction therapy patients undergo radiotherapy daily 5 days a week for 6 weeks
MAINTENANCE THERAPY Two weeks after the completion of radiotherapy patients receive additional tipifarnib as in induction therapy
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 54 patients will be accrued for this study within 11-14 months
I To estimate overall survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before and possibly after radiation therapy
SECONDARY OBJECTIVES
I To estimate response rate in adult patients with newly diagnosed glioblastoma multiforme treated with R115777 prior to therapy with radiation
II To estimate progression free survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before and possibly after radiation therapy
III To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme
OUTLINE This is a multicenter study
INDUCTION THERAPY Patients receive oral tipifarnib twice daily for 3 weeks Treatment repeats every 4 weeks for up to 3 courses
RADIOTHERAPY Within 14 days after the completion of induction therapy patients undergo radiotherapy daily 5 days a week for 6 weeks
MAINTENANCE THERAPY Two weeks after the completion of radiotherapy patients receive additional tipifarnib as in induction therapy
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 54 patients will be accrued for this study within 11-14 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 |
|---|---|---|---|
| U01CA062475 | NIH | None | httpsreporternihgovquickSearchU01CA062475 |
| NABTT 2200 | None | None | None |
| CDR285732 | None | None | None |