Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004212
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2000-01-28
Brief Title:
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase I Dose Escalation Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Pediatric Patients With Advanced Solid Tumors and Lymphomas
Status:
COMPLETED
Status Verified Date:
2012-05
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of DX-8951f in treating children who have advanced solid tumors or lymphomas that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of DX-8951f in treating children who have advanced solid tumors or lymphomas that have not responded to previous therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of exatecan mesylate DX-8951f with and without filgrastim G-CSF in pediatric patients with advanced solid tumors or lymphomas
Determine the toxic effects including dose-limiting toxicity of exatecan mesylate in these patients
Determine the pharmacokinetics of exatecan mesylate in these patients
Determine the recommended dose of exatecan mesylate for phase II study
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of exatecan mesylate DX-8951f Patients are stratified according to prior treatment minimally treated vs heavily treated
Patients receive exatecan mesylate IV over 30 minutes daily for 5 days Patients in dose levels 5 and above also receive filgrastim G-CSF subcutaneously beginning on day 6 and continuing for at least 7 days or until blood counts recover Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of exatecan mesylate with and without G-CSF 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
Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 45 patients will be accrued for this study
Determine the maximum tolerated dose of exatecan mesylate DX-8951f with and without filgrastim G-CSF in pediatric patients with advanced solid tumors or lymphomas
Determine the toxic effects including dose-limiting toxicity of exatecan mesylate in these patients
Determine the pharmacokinetics of exatecan mesylate in these patients
Determine the recommended dose of exatecan mesylate for phase II study
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of exatecan mesylate DX-8951f Patients are stratified according to prior treatment minimally treated vs heavily treated
Patients receive exatecan mesylate IV over 30 minutes daily for 5 days Patients in dose levels 5 and above also receive filgrastim G-CSF subcutaneously beginning on day 6 and continuing for at least 7 days or until blood counts recover Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of exatecan mesylate with and without G-CSF 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
Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 45 patients will be accrued for this study
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-V99-1573 | None | None | None |
| DAIICHI-8951A-PRT013 | None | None | None |
| MSKCC-99071 | None | None | None |
| UTHSC-9895011445 | None | None | None |