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

Central Hospital, Nancy, France

Status and phase: Completed; Phase 1

Conditions: Malignant Glioma

Treatments: Drug: Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02861222

2009-017803-27

Details and patient eligibility

About

The purpose of this study is to determine the toxicity and tolerance of Myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days.

Other purposes are to determine the recommended dose of Myocet and to assess the response to drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after Myocet administration will also be studied.

Enrollment: 13 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

MYOCET

Experimental group

Description:

2 treatments of doxorubicin are administered at 60 mg/m²/day or 75 mg/m²/day in single dose in 1-hour perfusion each 21 days. A maximum of 6 treatments/patient is administered.

Treatment:

Drug: Doxorubicin