Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00022451
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.
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.
Study:
NCT00022451
Study Brief:
Protocol Section:
NCT00022451