Tipifarnib in Treating Young Patients With Refractory Leukemia
|ClinicalTrials.gov Identifier: NCT00022451|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: tipifarnib||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia|
|Study Start Date :||June 2001|
|Actual Study Completion Date :||March 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022451
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|Study Chair:||Brigitte C. Widemann, MD||National Cancer Institute (NCI)|