Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Children's Hospital of Philadelphia
With
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.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
