Oxaliplatin in Treating Children With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.
|Unspecified Childhood Solid Tumor, Protocol Specific||Drug: oxaliplatin||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Oxaliplatin in Children With Solid Tumors|
|Study Start Date:||April 2000|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors.
- Determine the toxic effects of this drug in these patients.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients.
- Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD for dose levels 1-4 is determined, an additional cohort of 3-6 patients is accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses).
PROJECTED ACCRUAL: Approximately 6-20 patients will be accrued for this study within 1-3.3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005844
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|Study Chair:||Sheri L. Spunt, MD||St. Jude Children's Research Hospital|