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.
OBJECTIVES: * 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
3-6 subjects will be enrolled into each dose level
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Toxicity as assessed by Common Toxicity Criteria (CTC) toxicity criteria after the first course of treatment
Subjects will be assessed for toxicity on days 3, 7 and 21
Time frame: within 21 days following administration of sirolimus
Response as assessed by radiologic scans after each course of treatment
Response will be assessed on day 21 of cycle 1
Time frame: day 21
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