Trials / Completed
CompletedNCT00015899
SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Pediatric Brain Tumor Consortium · Network
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors.
Detailed description
OBJECTIVES: * Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors. * Estimate the maximum tolerated dose of this drug in these patients. * Describe the pharmacokinetics of this drug with and without dexamethasone in these patients. * Investigate the efficacy of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral SCH 66336 twice daily. Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is predicted that 20% of patients may experience dose-limiting toxicity. An additional 6 patients are treated at the determined MTD. Patients are followed within 30 days of the last administration of the study drug and then for up to 3 months. PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lonafarnib |
Timeline
- Start date
- 2002-01-01
- Primary completion
- 2005-09-01
- Completion
- 2007-03-01
- First posted
- 2003-01-27
- Last updated
- 2009-10-14
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00015899. Inclusion in this directory is not an endorsement.