Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma

Inclusion criteria

• Patients having received at least one cycle of chemotherapy after radiotherapy
• Patients having grade III or IV (WHO) glioma, not localized in brainstem
• Tumor measurable with magnetic resonance imaging
• Absence of other concomitant anti-cancer treatments
• Absence of chemotherapy for 4 weeks; 6 weeks if nitrosourea
• Good general health and nutritional status according to NCI-CTC scale (version 3) (appendix 6)
• Lansky score > 50% or Karnofsky > 50 in children older than 12 years
• Absence of organ toxicity (grade > 2 according to NCI-CTC criteria (version 3)
• Hematology: polynuclear neutrophil count > 1.0 x 109/l
• Hematology: platelet count > 100 x 109/l
• Liver function: bilirubinemia < 1.5 normal value
• Liver function: ASAT and ALAT levels < 2.5 normal values
• Liver function: prothrombin level > 70%
• Liver function: fibrinogen > 1.5 g/l
• Renal function: creatinemia < 1.5 normal value/age
• Cardiac function: EF > 60% and/or SF > 30%
• Signature of informed consent by patient if adolescent, by 2 parents or legal guardian if minor patient
• For patients with childbearing potential, a contraceptive method is compulsory. This contraception must be continued 6 months after Myocet treatment end
• For patients with childbearing potential, negative pregnancy test (betahCG test)

Exclusion criteria

• Non compliance with eligibility criteria
• Severe or life-threatening infection
• Non controlled evolutive or symptomatic intracranial hypertension
• History of Myocet treatment, but patients could be treated with anthracyclines if cardiac function is normal
• Hypersensibility to the active substance, to premixtures or one of excipients
• Pregnancy and breastfeeding