RecruitingPhase 2NCT04469530

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

A Maintenance Protocol of Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors

Sponsor

Emory University

Enrollment

55 participants

Start Date

Sep 16, 2020

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

Summary

The primary objective of this study is to improve the 2-year progression-free survival in children with high-risk solid tumors who are administered a maintenance regimen with continuous sirolimus administered on a backbone of metronomic chemotherapy following the completion of "standard" therapy, as compared to high-risk solid tumor patients treated with observation alone following completion of "standard" therapy.

Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Celecoxib, a drug called Cyclophosphamide, and others for people with solid tumor. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 1 Year to 30 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSirolimus

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.

DRUGCyclophosphamide

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.

DRUGEtoposide

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.

DRUGCelecoxib

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