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Drug everolimus shows promise in slowing Children's brain tumors

NCT ID NCT01734512

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested the drug everolimus in 65 children whose low-grade gliomas had come back or worsened. The goal was to see if the drug could stop or slow tumor growth. Children took everolimus pills daily, and doctors tracked tumor changes with MRI scans. The study focused on how many children remained progression-free after 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Everolimus (a drug that blocks a protein called mTOR to slow tumor growth)
What this could lead to
If successful, everolimus could offer a new treatment option to control tumor growth and delay progression in children with low-grade gliomas.
What could go wrong
This is a small, single-arm phase 2 study without a placebo group, so results may not be definitive. The drug may cause side effects like mouth sores, infections, or metabolic changes.

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

65 people

The number who actually took part.

Started

Dec 2012

Finished

Jul 2024

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

3 to 21 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: --Patients must have radiographic progressive or recurrent confirmed world health organization (WHO) grade I or II astrocytomas, that was confirmed histologically. Progressive or recurrent disease should be based on MRI according to the definition below. Eligible histologies: * Pilocytic Astrocytoma - 90600112 * Astrocytoma, Low Grade (Fibrillary astrocytoma, WHO Grade 2) - 10065886 * Astrocytoma, Low Grade (Low-grade Astrocytoma, not otherwise specified (NOS), WHO Grade 2) - 10003571 * Tissue from the initial diagnosis or recurrence must be made available for correlative testing. * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions on MRI. * Patients may have had treatment (chemotherapy and/or radiotherapy) for any number of relapses prior to this recurrence. * Patients must have received their last dose of myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration or at least six (6)weeks of nitrosourea. * Patients must have received their last dose of other investigational or biological agent \> 7 days prior to study entry. For agents that have known adverse events occurring beyond 7 days after administration, this period should be extended beyond the time during which adverse events are known to occur. This should be discussed with the study chair. * If patients received prior monoclonal antibody treatment, at least three half-lives must be elapsed by the time of treatment initiation. These patients should also be discussed with the study chair. * Patients must have received their last fraction of craniospinal or focal radiation to primary tumor or other sites \>12 weeks (3 months) prior to registration. --Age ≥3 and ≤21 years. * Because no dosing or adverse event data are currently available on the use of everolimus in patients \<3 years of age, these young children are excluded from this study. * Life expectancy of greater than 8 weeks. * Patients must be able to swallow pills. * Patient must have a Karnofsky (if ≥ 16 years of age) or Lansky Performance score (if ≤ 16 years of age) of ≥50 by the time of registration. * Patients must have adequate bone marrow function (ANC ≥ 1,000/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin ≥ 9 gm/dL) before starting therapy. Eligibility level for hemoglobin may be reached by transfusion. * International Normalized Ratio (INR) ≤1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for \>2 weeks at time of randomization). * Patients must have adequate liver function (SGPT/alanine aminotransferase (ALT) ≤ 2.5 times ULN and bilirubin ≤ 1.5 times ULN) before starting therapy. * Patients must have adequate renal function (serum creatinine ≤ 1.5 times institutional ULN for age or Glomerular filtration rate (GFR) ≥ 70 ml/min/1.73 m2) before starting therapy. * Patients must have cholesterol level \<350 mg/dL and triglycerides \< 400 mg/dL before starting therapy. In case one or both of these are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol \< 350mg/dL and triglycerides \< 400mg/dl before start of therapy. * Patients must have normal pulmonary function testing for age based on pulse oximetry. * The effects of everolimus on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because everolimus are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Female patients of child bearing potential must not be breastfeeding or pregnant as evidenced by a negative pregnancy test. Exclusion Criteria: * Patients with primary spinal cord tumors * Patients receiving concomitant medication that may interfere with study outcome. For example, patients cannot be on enzyme inducing anticonvulsants like phenytoin. * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, bacille Calmette-Guerin (BCG), yellow fever, varicella and TY21a typhoid vaccines * Hepatitis B/C blood test must be done at screening for all patients. Patients who test positive for Hepatitis C antibodies and the Hepatitis B antigen are ineligible. * A known history of HIV seropositivity. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with everolimus. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed. * Patients may not have therapy for this recurrence (including radiation). * Patients who do not have measurable disease on MRI. * Patients who have been previously treated with an mTOR inhibitor. * Patients with a known hypersensitivity to everolimus or other rapamycins (e.g. sirolimus, temsirolimus). * Patients receiving any other concurrent anticancer or investigational therapy. * Patients with any clinically significant unrelated systemic illness that would compromise the patient's ability to tolerate protocol therapy. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection. * Patients with inability to return for follow-up visits to assess toxicity to therapy. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B Virus (HBV) DNA and Hepatitis C Virus (HCV) RNA Polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.

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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

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital Oakland

    Oakland, California, 94609, United States

  • Children's Hospitals and Clinics of Minneapolis

    Minneapolis, Minnesota, 55404, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • St. Louis Children's Hospital, Washington University

    St Louis, Missouri, 63130, United States

  • The Children's Hospital Of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • University of California, Los Angeles

    Los Angeles, California, 90027, United States

  • University of California, San Diego Rady Children's Hospital

    San Diego, California, 92123, United States

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • University of Washington, Seattle

    Seattle, Washington, 98195, United States

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