Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019630
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-01
Brief Title:
Liposomal Doxorubicin in Treating Children With Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Doxorubicin HCl Liposome in Pediatric Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-03
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 liposomal doxorubicin in treating children who have refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of liposomal doxorubicin in treating children who have refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the tolerance to and toxicity profile of doxorubicin HCl liposome Lipodox at standard doxorubicin doses and doses of Lipodox that were tolerable in adults administered every 3 weeks in pediatric patients with refractory solid tumors
II Determine the maximum tolerated dose of this drug in these patients if dose-limiting toxicity is observed at doses of 105 mgm2 or less
III Determine the pharmacokinetics of this drug in these patients IV Assess the cardiotoxicity of this drug in children who have previously been treated with free doxorubicin and in children who have not previously received doxorubicin
V Evaluate the feasibility of using cardiac MRI functional imaging as a screening tool for the quantitative assessment of doxorubicin-induced cardiotoxicity
VI Determine if serum troponin t levels are a useful biomarker for doxorubicin-induced myocardial damage
PROTOCOL OUTLINE This is a dose-escalation multicenter study Patients receive doxorubicin HCl liposome IV over 60 minutes Treatment repeats every 4 weeks for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 4-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 4 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL
A total of 21-36 patients will be accrued for this study within 1-2 years
II Determine the maximum tolerated dose of this drug in these patients if dose-limiting toxicity is observed at doses of 105 mgm2 or less
III Determine the pharmacokinetics of this drug in these patients IV Assess the cardiotoxicity of this drug in children who have previously been treated with free doxorubicin and in children who have not previously received doxorubicin
V Evaluate the feasibility of using cardiac MRI functional imaging as a screening tool for the quantitative assessment of doxorubicin-induced cardiotoxicity
VI Determine if serum troponin t levels are a useful biomarker for doxorubicin-induced myocardial damage
PROTOCOL OUTLINE This is a dose-escalation multicenter study Patients receive doxorubicin HCl liposome IV over 60 minutes Treatment repeats every 4 weeks for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 4-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 4 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL
A total of 21-36 patients will be accrued for this study within 1-2 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-99-C-0039 | None | None | None |
| NCI-99-C-0039F | None | None | None |
| LIPO-NCI-99-C-0039 | None | None | None |