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Promising combo aims to tame relapsed childhood cancers

NCT ID NCT02574728

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

46 people

The number who actually took part.

Start date

Jun 2015

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

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

12 months to 30 years

Sex

Anyone

Healthy volunteers

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

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

  • Children's Healthcare of Atlanta, Scottish Rite

    Atlanta, Georgia, 30342, United States

  • Children's Healthcare of Atlanta-Egleston

    Atlanta, Georgia, 30322, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Nemours/Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.