Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022451
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2001-08-10
Brief Title:
Tipifarnib in Treating Young Patients With Refractory Leukemia
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia
Status:
COMPLETED
Status Verified Date:
2012-03
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:
RATIONALE Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia
PURPOSE Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and toxicity profile of tipifarnib in pediatric patients with refractory leukemia
Determine the pharmacokinetics of this drug in these patients
Determine the toxicity profile of this drug in these patients
Secondary
Analyze the gene expression profile of leukemic blasts from these patients before and after treatment with this drug
Determine circulating levels of nerve growth factor and correlate these levels with clinical neurotoxicity from this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral tipifarnib every 12 hours on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 6 patients experience dose-limiting toxicity At least 9 additional patients are treated at the MTD
PROJECTED ACCRUAL A total of 12-34 patients will be accrued for this study within 1-2 years
Primary
Determine the maximum tolerated dose and toxicity profile of tipifarnib in pediatric patients with refractory leukemia
Determine the pharmacokinetics of this drug in these patients
Determine the toxicity profile of this drug in these patients
Secondary
Analyze the gene expression profile of leukemic blasts from these patients before and after treatment with this drug
Determine circulating levels of nerve growth factor and correlate these levels with clinical neurotoxicity from this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral tipifarnib every 12 hours on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 6 patients experience dose-limiting toxicity At least 9 additional patients are treated at the MTD
PROJECTED ACCRUAL A total of 12-34 patients will be accrued for this study within 1-2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068819 | None | None | None |
| 01-C-0196C | None | None | None |
| COG-ADVL0116 | None | None | None |
| NCI-1930 | None | None | None |