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Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors
Sponsor: Emory University
Summary
This study aims to determine the efficacy of daily sirolimus and celecoxib, with low dose etoposide alternating with cyclophosphamide for pediatric participants with relapsed or refractory tumors.
Official title: AflacST1502: A Phase II Study of Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors
Key Details
Gender
All
Age Range
12 Months - 30 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2015-06
Completion Date
2026-06
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Sirolimus
The starting dose for sirolimus is 2 mg/m2 once daily. The dose of sirolimus will be individually adjusted to achieve a target serum trough concentration in the range of 10-15 ng/ml. Sirolimus will be given by mouth every day for six weeks (every six weeks is called one cycle) for up to two years or 16 cycles.
Celecoxib
Celecoxib 100 mg will be given by mouth twice a day for six weeks (every six weeks is called one cycle) for up to two years or 16 cycles.
Etoposide
Etoposide 50 mg/m2 (maximum dose 100 mg) will be given daily by mouth for the first 3 weeks of a 6 week cycle. Six week cycles will be repeated for up to two years or 16 cycles.
Cyclophosphamide
Cyclophosphamide 2.5 mg/Kg (maximum dose 100 mg) will be given daily by mouth for the second 3 weeks of a 6 week cycle. Six week cycles will be repeated for up to two years or 16 cycles.
Locations (6)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, United States
Children's Healthcare of Atlanta, Scottish Rite
Atlanta, Georgia, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of Virginia Health System
Charlottesville, Virginia, United States