Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-10 @ 5:29 PM
Study NCT ID:
NCT00112892
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2005-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan and Selenium in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-01
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, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with selenium may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors.
Detailed Description:
OBJECTIVES:
Primary
* Determine the optimal loading and maintenance doses of selenium necessary to achieve selenium concentrations exceeding 15 μM when administered with irinotecan in patients with advanced solid tumors.
Secondary
* Determine the pharmacokinetics of this regimen in these patients.
* Determine the toxic effects of this regimen in these patients.
* Determine any observed tumor response to this regimen in these patients.
OUTLINE: This is a dose-escalation study of selenium.
Patients receive a loading dose\* of oral selenium twice daily on days -6 to 0. Patients then receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
NOTE: \*The loading dose is administered prior to course 1 only.
Cohorts of 3-6 patients receive escalating doses of selenium until the maximum tolerated dose (MTD) 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. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18 months.
Primary
* Determine the optimal loading and maintenance doses of selenium necessary to achieve selenium concentrations exceeding 15 μM when administered with irinotecan in patients with advanced solid tumors.
Secondary
* Determine the pharmacokinetics of this regimen in these patients.
* Determine the toxic effects of this regimen in these patients.
* Determine any observed tumor response to this regimen in these patients.
OUTLINE: This is a dose-escalation study of selenium.
Patients receive a loading dose\* of oral selenium twice daily on days -6 to 0. Patients then receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
NOTE: \*The loading dose is administered prior to course 1 only.
Cohorts of 3-6 patients receive escalating doses of selenium until the maximum tolerated dose (MTD) 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. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18 months.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RPCI-I-32804 | None | None | View |