Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068302
Status:
TERMINATED
Last Update Posted:
2015-03-12
First Post:
2003-09-10
Brief Title:
Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkins Lymphoma
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
A Phase I Trial Of Sirolimus In RelapsedRefractory Leukemia And Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitingenrolling participants halted prematurely but potentially will resume
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 sirolimus use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of sirolimus in treating young patients with relapsed or refractory acute leukemia or non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of sirolimus in treating young patients with relapsed or refractory acute leukemia or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of sirolimus in pediatric patients with refractory or relapsed acute leukemia or non-Hodgkins lymphoma
Determine the dose-limiting toxic effects of this drug in these patients
Determine the trough levels produced by this drug in these patients
Determine the anti-leukemialymphoma activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral sirolimus once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sirolimus 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
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 2 years
Determine the maximum tolerated dose of sirolimus in pediatric patients with refractory or relapsed acute leukemia or non-Hodgkins lymphoma
Determine the dose-limiting toxic effects of this drug in these patients
Determine the trough levels produced by this drug in these patients
Determine the anti-leukemialymphoma activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral sirolimus once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sirolimus 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
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 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 |
|---|---|---|---|
| CHP-IRB-2002-12-3086 | None | None | None |
| CHP-755 | None | None | None |