Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas (NCT02115074) | Clinical Trial Compass
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 range
6 Years – 21 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial that has already completed, has the maximum tolerated dose of fluvastatin combined with Celebrex been established, and what did the safety results show — were there any serious side effects I should know about?
2This trial specifically studied optico-chiasmatic gliomas — does my particular tumor location and grade match the types studied here, and would that affect whether this combination might be relevant to my care?
3Because this was a Phase 1 study focused on finding a safe dose rather than proving the treatment works, what evidence of effectiveness, if any, came out of it, and are there follow-up Phase 2 or 3 trials I should look into?
4Fluvastatin is a cholesterol-lowering drug and Celebrex is an anti-inflammatory — can you help me understand why combining these two drugs might matter for a brain tumor like mine, and whether that approach is now being used outside of a trial?
5Given that this trial is completed, would you recommend I consider a currently active trial or standard treatment instead, and how does what was learned here factor into that decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) of Fluvastatine combined to a fixed-dose of Celebrex
Timeframe: 28 days (at the end of the first cycle)