Promising combo aims to tame relapsed childhood cancers
NCT ID NCT02574728
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a daily combination of sirolimus, celecoxib, and low-dose chemotherapy in 46 children whose solid or brain tumors have returned or not responded to standard treatment. The goal is to see if this approach can shrink tumors or stop them from growing. While not a cure, it offers a potential way to control the disease and manage symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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46 people
The number who actually took part.
- Start date
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Jun 2015
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 months to 30 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Healthcare of Atlanta, Scottish Rite
Atlanta, Georgia, 30342, United States
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Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, 30322, United States
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Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
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Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
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Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
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University of Virginia Health System
Charlottesville, Virginia, 22908, United States
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Other studies related to the condition(s) this trial covers.
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