Could a statin and arthritis drug tame childhood brain cancer?
NCT ID NCT02115074
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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20 people
The number who actually took part.
- Started
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Jun 2014
- Finished
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Jan 2022
- 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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6 to 21 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: * 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
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CHU Angers
Angers, 49933, France
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Centre Hospitalier de Nancy
Vandœuvre-lès-Nancy, 54511, France
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Centre Hospitalier de Purpan - Hôpital des Enfants
Toulouse, 31026, France
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Centre Hospitalier de Strasbourg
Strasbourg, 67098, France
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Centre Léon Bérard
Lyon, 69373, France
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Centre Oscar Lambret
Lille, 59020, France
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Hôpital pour enfants La Timone
Marseille, 13385, France
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Institut Curie
Paris, 75005, France
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