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

Running, not enrolling · Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT02574728

Run by

Emory University

People needed

46

Starts

2015-06-01

Expected to finish

2026-06-01

Last updated by the study team

2026-03-02

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with any of the following tumors who have experienced relapse following front-line therapy, or who are refractory to front-line therapy, and participants with tumors that carry a poor prognosis and have no known standard curative therapy
• Brain tumors of all World Health Organization (WHO) grades, except diffuse intrinsic pontine glioma (DIPG) - enrollment in the brain tumor stratum is closed
• Extracranial solid tumors including histiocytoses
• Participants must have had a histologic verification of malignancy at original diagnosis or relapse, except in participants with optic pathway gliomas, or participants with pineal tumors and elevations of serum or cerebrospinal fluid (CSF) alpha-fetoprotein (AFP) or beta-human chorionic gonadotropin (beta-HCG)
• Tissue blocks or slides must be sent
• Participants must have radiographically measurable disease at the time of study enrollment to be eligible. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG+) evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as tumor that is measurable (≥ 10 mm) in two perpendicular diameters on MRI and visible on more than one slice. For all patients, tumors that are located in a previously irradiated area may be considered measurable if the lesion has shown tumor growth after radiation or has been biopsied and proven to have active disease.
• Participant's current disease state must be one for which there is no known curative therapy
• Karnofsky performance level of greater than or equal to 50 percent for participants who are greater than 16 years of age at the time of screening
• Lansky performance level of greater than or equal to 50 percent for participants who are less than or equal to 16 years of age at the time of screening
• Fully recovered from acute toxic effects of all prior anti-cancer therapy
• Adequate bone marrow function as deemed by the protocol at the time of screening
• Adequate renal function as deemed by the study protocol at the time of screening
• Adequate liver function as deemed by the study protocol at the time of screening
• Serum triglyceride level ≤300 mg/dL and serum cholesterol ≤ 300 mg/dL
• Random or fasting blood glucose within the upper normal limits for age
• Adequate pulmonary function as deemed by the study protocol at the time of screening

You may not qualify if…

• Women who are currently pregnant or breastfeeding
• Receiving corticosteroids who have not been on a stable dose for at least 7 days
• Currently receiving enzyme inducing anticonvulsants
• Currently receiving receiving potent CYP3A4 (enzyme) inducers or inhibitors
• Currently receiving another investigational drug
• Currently receiving any other anti-cancer agents
• The use of cannabis oil is prohibited during the first 2 cycles of this protocol. Patients must be off of cannabis oil for 3 days prior to enrollment.
• Uncontrolled infection
• Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.