Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00068302|
Recruitment Status : Terminated (Recruiting/enrolling participants halted prematurely but potentially will resume)
First Posted : September 11, 2003
Last Update Posted : March 12, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: sirolimus||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial Of Sirolimus In Relapsed/Refractory Leukemia And Non-Hodgkin's Lymphoma|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||July 2013|
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
- 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 ]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 ]Response will be assessed on day 21 of cycle 1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068302
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Susan Rheingold, MD||Children's Hospital of Philadelphia|