Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
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-Hodgkin's lymphoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial Of Sirolimus In Relapsed/Refractory Leukemia And Non-Hodgkin's Lymphoma|
- Toxicity as assessed by Common Toxicity Criteria (CTC) toxicity criteria after the first course of treatment [ Time Frame: within 21 days following administration of sirolimus ] [ Designated as safety issue: Yes ]Subjects will be assessed for toxicity on days 3, 7 and 21
- Response as assessed by radiologic scans after each course of treatment [ Time Frame: day 21 ] [ Designated as safety issue: No ]Response will be assessed on day 21 of cycle 1
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
This is a dose escalation study including 4-dose levels. Subjects will receive a one-time loading dose of sirolimus on day 0, time 0. Subsequent dosing at the assigned dose level will start 24 hours following the initial loading dose
3-6 subjects will be enrolled into each dose level
- Determine the maximum tolerated dose of sirolimus in pediatric patients with refractory or relapsed acute leukemia or non-Hodgkin's 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-leukemia/lymphoma 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068302
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Susan Rheingold, MD||Children's Hospital of Philadelphia|