Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (6)

19803

Nemours/Alfred I. duPont Hospital for Children, Wilmington

22908

University of Virginia Health System, Charlottesville

30322

Children's Healthcare of Atlanta-Egleston, Atlanta

30342

Children's Healthcare of Atlanta, Scottish Rite, Atlanta

64108

Children's Mercy Hospital, Kansas City

85016

Phoenix Children's Hospital, Phoenix

All Listed Sponsors
collaborator

Cannonball Kids' Cancer Foundation

OTHER

collaborator

Hyundai Hope On Wheels

OTHER

lead

Emory University

OTHER