Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049387
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2002-11-12
Brief Title:
Tipifarnib Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of R115777 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This phase I trial is studying the side effects and best dose of tipifarnib when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor 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 or by stopping them from dividing Radiation therapy uses high-energy x-rays to damage tumor cells Combining tipifarnib temozolomide and radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Establish MTD for R115777 in combination with Temozolomide with radiation in patients not on EIAEDs
II To define the safety of R115777 in combination with Temozolomide with radiation in this patient population
III To assess for evidence of antitumor activity in this patient population
OUTLINE This is a multicenter dose-escalation study of tipifarnib Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs yes closed to accrual as of 31505 vs no
COMBINATION THERAPY Patients receive oral tipifarnib twice daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Within 5-9 days after beginning tipifarnib patients receive oral temozolomide once daily for 6 weeks and concurrently undergo partial brain radiotherapy daily 5 days a week for 6 weeks After completion of radiotherapy patients proceed to adjuvant therapy
Cohorts of 3-6 patients receive escalating doses of tipifarnib 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 An additional 10 patients are treated at the MTD
ADJUVANT THERAPY Patients continue to receive tipifarnib as above With the initiation of the next planned course of tipifarnib patients receive oral temozolomide on days 1-5 Treatment repeats every 28 days for 12 courses OR 1 year whichever is longer in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients with progressive disease are followed at 10 weeks and then every 4 months Patients who complete therapy are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year and then every 6 months thereafter until disease progression
I Establish MTD for R115777 in combination with Temozolomide with radiation in patients not on EIAEDs
II To define the safety of R115777 in combination with Temozolomide with radiation in this patient population
III To assess for evidence of antitumor activity in this patient population
OUTLINE This is a multicenter dose-escalation study of tipifarnib Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs yes closed to accrual as of 31505 vs no
COMBINATION THERAPY Patients receive oral tipifarnib twice daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Within 5-9 days after beginning tipifarnib patients receive oral temozolomide once daily for 6 weeks and concurrently undergo partial brain radiotherapy daily 5 days a week for 6 weeks After completion of radiotherapy patients proceed to adjuvant therapy
Cohorts of 3-6 patients receive escalating doses of tipifarnib 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 An additional 10 patients are treated at the MTD
ADJUVANT THERAPY Patients continue to receive tipifarnib as above With the initiation of the next planned course of tipifarnib patients receive oral temozolomide on days 1-5 Treatment repeats every 28 days for 12 courses OR 1 year whichever is longer in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients with progressive disease are followed at 10 weeks and then every 4 months Patients who complete therapy are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year and then every 6 months thereafter until disease progression
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 |
|---|---|---|---|
| NCI-2012-03106 | REGISTRY | None | None |
| NCI-03-C-0189 | None | None | None |
| NABTC-0202 | None | None | None |
| NABTC-02-02 | OTHER | None | None |
| NABTC-02-02 | OTHER | None | None |
| U01CA062399 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062399 |