CompletedPhase 1

Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas

France20 participantsStarted 2014-06

Plain-language summary

Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a secondary role. Unlike other sites, many of these tumors are not amenable to complete resection either because of anatomical location, and sometimes they only can be biopsied. A substantial number of children will have recurrences following resection or will experience progression following incomplete tumor removal or biopsy. Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins are known to increase the sensitivity of gliomas to anti-tumor agents. Their association could be administered for long periods, in the hope of much reduced risk of toxicities. This is a national, multicentric, interventional, open-label, non-comparative, and non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in combination with fixed-dose of Celebrex. This project involves 10 SFCE health centers accustomed to phase I / II studies(Société Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French Society for the Fight against Cancer and Leukemia in Children and Adolescents).

Who can participate

Age range6 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 insu…

What they're measuring

Maximum tolerated dose (MTD) of Fluvastatine combined to a fixed-dose of Celebrex

Timeframe: 28 days (at the end of the first cycle)

Trial details

NCT IDNCT02115074

SponsorCentre Oscar Lambret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11