Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005844
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2000-06-02
Brief Title:
Oxaliplatin in Treating Children With Advanced Solid Tumors
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Phase I Study of Oxaliplatin in Children With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors
Detailed Description:
OBJECTIVES
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 1-33 years
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 1-33 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0059 | OTHER | National Cancer Institute | None |
| SJCRH-OXAL1 | OTHER | None | None |