Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
Recruitment status was Recruiting
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:||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 CTC toxicity criteria after the first course of treatment [ Designated as safety issue: Yes ]
- Response as assessed by radiologic scans after each course of treatment [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
- 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.
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Susan Rheingold, MD 215-590-2801 firstname.lastname@example.org|
|Study Chair:||Susan Rheingold, MD||Children's Hospital of Philadelphia|