Clinical Trial Details
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NCT02115074 : Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas
PhasePhase 1
AgesMin: 6 Years Max: 21 Years
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

- 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

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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