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ACTIVE NOT RECRUITING
NCT02574728
PHASE2

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

Sponsor: Emory University

View on ClinicalTrials.gov

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

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.

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