Trials / Completed
CompletedNCT00022451
Tipifarnib in Treating Young Patients With Refractory Leukemia
A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Institutes of Health Clinical Center (CC) · NIH
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tipifarnib |
Timeline
- Start date
- 2001-06-01
- Completion
- 2005-03-01
- First posted
- 2003-01-27
- Last updated
- 2012-03-15
Locations
61 sites across 3 countries: United States, Australia, Canada
Source: ClinicalTrials.gov record NCT00022451. Inclusion in this directory is not an endorsement.