Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016861
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-06-06
Brief Title:
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
Sponsor:
Texas Childrens Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pediatric Phase I and Pharmacokinetic Study of Irinotecan
Status:
COMPLETED
Status Verified Date:
2004-11
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 irinotecan in treating children who have refractory or progressive solid tumors
PURPOSE Phase I trial to study the effectiveness of irinotecan in treating children who have refractory or progressive solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan in children with refractory or progressive solid tumors
Determine the pharmacokinetics of this drug and its metabolites SN-38 SN-38G and APC administered with and without concurrent anticonvulsants in this patient population
Determine the benefit this drug offers this patient population
OUTLINE This is a dose-escalation multicenter study Patients are accrued into stratum 1 initially and into stratum 2 if stratum 1 closes due to dose-limiting toxicity of myelosuppression or diarrhea Patients on anticonvulsants will be accrued into stratum 3 and must meet the eligibility criteria for the stratum that is open stratum 1 or stratum 2 Stratum 1 closed as of 2002-09-15
Patients receive irinotecan IV over 90 minutes weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD with and without anticonvulsants is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL Approximately 20-25 patients will be accrued for this study
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan in children with refractory or progressive solid tumors
Determine the pharmacokinetics of this drug and its metabolites SN-38 SN-38G and APC administered with and without concurrent anticonvulsants in this patient population
Determine the benefit this drug offers this patient population
OUTLINE This is a dose-escalation multicenter study Patients are accrued into stratum 1 initially and into stratum 2 if stratum 1 closes due to dose-limiting toxicity of myelosuppression or diarrhea Patients on anticonvulsants will be accrued into stratum 3 and must meet the eligibility criteria for the stratum that is open stratum 1 or stratum 2 Stratum 1 closed as of 2002-09-15
Patients receive irinotecan IV over 90 minutes weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD with and without anticonvulsants is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL Approximately 20-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V01-1654 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068568 | REGISTRY | None | None |
| TCCC-GCRC-0654 | None | None | None |