Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 16, 2020

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Solid Tumor
Interventions
DRUG

Sirolimus

Sirolimus is given at a dose of 2 mg/m2 once daily. The amber oral dose syringe should be used to withdraw the prescribed amount of sirolimus oral solution from the bottle. The solution can be drunk or administered at once to assure delivery of all of the medication. It is safe for administration through a nasogastric or G-tube. For tablets, the tablet should not be crushed, split, or otherwise altered. As with the liquid dosing form, the tablets should be given within two hours each day and should be at consistent intervals with regard to meals.

DRUG

Cyclophosphamide

"A synthetic antineoplastic drug chemically related to the nitrogen mustards. The drug is administered orally daily, in the formulation appropriate for age.~The solution should be diluted in 20-30 ml of appropriate liquid before administration through nasogastric (NG) tube or gastrostomy (G) tube, with adequate flushing after administration to prevent obstruction of the feeding tube."

DRUG

Etoposide

A semisynthetic derivative of podophyllotoxin which functions as mitotic inhibitor but does not interfere with microtubular assembly. The drug is administered orally daily, in the formulation appropriate for age.

DRUG

Celecoxib

The drug is administered orally daily, in the formulation appropriate for age.The solution is safe for administration through a nasogastric or G-tube.

Trial Locations (5)

15224

RECRUITING

Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC), Pittsburgh

30322

RECRUITING

Aflac Cancer & Blood Disorders Centers, Atlanta

RECRUITING

Children's Healthcare of Atlanta, Atlanta

63110

RECRUITING

Washington University School of Medicine, St Louis

77030

RECRUITING

Texas Children's Cancer Center, Houston

All Listed Sponsors
collaborator

PeachBowl LegACy Fund

UNKNOWN

lead

Emory University

OTHER