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Could a statin and arthritis drug tame childhood brain cancer?

NCT ID NCT02115074

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a combination of two drugs—fluvastatin (a cholesterol-lowering statin) and celecoxib (an arthritis drug)—in 20 children and young adults with certain brain tumors (gliomas) that had come back or not responded to treatment. The goal was to find the safest dose of fluvastatin when given with a fixed dose of celecoxib, and to see if the combo could help control the disease. The study was completed, but results are not yet reported.

What this could mean

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

Active substance
Fluvastatin and Celecoxib (Celebrex)
What this could lead to
If this works, it could point toward a new way to control certain childhood brain tumors without harsh side effects.
What could go wrong
This is a very early, small phase 1 trial with only 20 participants. It is designed to find a safe dose, not to prove the treatment works. The drugs may not shrink tumors or improve survival.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Jun 2014

Finished

Jan 2022

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

6 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: * Histologically confirmed recurrent or progressive primary hypothalamic-chiasmatic low grade glioma, and not warranting a biopsy or surgery * Histologically confirmed recurrent or progressive primary hypothalamic-chiasmatic high grade glioma, or in complete remission after a new exeresis, excepted brainstem gliomas * Relapsed or refractory disease after at least 1 line adjuvant treatment including radiation therapy, but not surgery * Measurable lesions according to RANO criteria for the patients with low grade glioma and for the patients with high grade glioma included in RP2D level (Recommended Phase 2 Dose). * Non-measurable lesions according to RANO criteria for patients with high grade glioma included in the dose escalation step. * Age \> 6 years and \< 21 years old * Lansky score \> 70 or WHO score \< 2 (neurological conditions associated with the disease should not be taken into consideration) * Haematological conditions: ANC \> 1000/mm3 and platelets \> 75000/mm3 * Creatinine \< 1.5 x normal for age or calculated clearance \> 70 ml/mn/1.73m2 * Hepatic function: Total bilirubin \< 3 N and SGOT and SGPT \< 4 N * Muscle enzymes : CPK \< 2 N * No organ toxicity superior to grade 2 according to NCI-CTCAE v4.0 * No allergy, hypersensibility to one of the compounds of the treatment * Patients able to swallow capsules * Life expectancy at least \> 6 months for low grade gliomas and \> 3 months for high grade gliomas * Patient affiliated with a health insurance system * Effective contraception for patients (male and female) with reproductive potential throughout the treatment period * Written informed consent of patient and/or parents/guardians prior to the study participation Exclusion Criteria: * Chemotherapy within 21 days before D1 of experimental treatment. This period may be shortened in case of previous chemotherapy with vincristine (2 weeks), or extended in case of targeted therapies (4 weeks), or treatment by nitrosoureas (6 weeks) * Radiotherapy within 6 months before D1 of experimental treatment * Peptic ulcer disease, or gastrointestinal bleeding * Known hypersensitivity to sulfonamides. * History of asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic-type reactions induced by acetylsalicylic acid or NSAIDs , including COX-2 inhibitors (cyclo-oxygenase- 2) * Inflammatory bowel disease. * Known congestive heart failure (NYHA II- IV) * Ischemic proven, peripheral and/or history of arterial stroke (including transient ischemic attack) * Pregnancy or breast feeding woman * Known allergy to experimental treatment * Organ toxicity superior to grade 2 according to NCI-CTCAE v4.0 * Active infection * Pre-existing muscle pathology * Unsuitable for medical follow-up (geographic, social or mental reasons)

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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

  • CHU Angers

    Angers, 49933, France

  • Centre Hospitalier de Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Hospitalier de Purpan - Hôpital des Enfants

    Toulouse, 31026, France

  • Centre Hospitalier de Strasbourg

    Strasbourg, 67098, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Hôpital pour enfants La Timone

    Marseille, 13385, France

  • Institut Curie

    Paris, 75005, France

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