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

Phase 1

Completed

• Conditions: Malignant Glioma
• Interventions: Drug: Doxorubicin

• Registration Number: NCT02861222
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Study First Posted: 2016-08-10
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MYOCET	Doxorubicin	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.

Primary Outcome Measures

Name	Time	Method
Complete blood count (platelet included)	2 times/week from day 0
ALAT/ASAT measurement	From day 21 post-dose
Bilirubin test	From day 21 post-dose
Prothrombin test	From day 21 post-dose
Fibrin measurement	From day 21 post-dose
Partial thromboplastin time test	From day 21 post-dose
Creatinine blood test	From day 21 post-dose
Analysis of the electrolyte composition of the blood	From day 21 post-dose
Blood urea analysis	From day 21 post-dose
Glycemia analysis	From day 21 post-dose
General health evaluation	From day 21 post-dose	NCI-CTC scale, version 3, appendix 6
Changes in neurological condition related to the tumor (motor deficit, sensory deficit, cranial nerves pairs defect, cerebellar syndrome, vertebrobasilar defect, pyramidal tract syndrome) assessed during clinical examination	From day 21 post-dose
Echocardiography with analysis of ventricular ejection and shortening fractions	From day 21 post-dose
Normality of ECG	From day 21 post-dose
Calcemia analysis	From day 21 post-dose
Protidaemia analysis	From day 21 post-dose

Secondary Outcome Measures

Name	Time	Method
Measure of initial tumors with MRI	from day 42, after each 2 treatments
Antitumoral activity (radiological criteria of SIOP protocol)	from day 42, after each 2 treatments
Plasma measurement of free doxorubicin	0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of encapsulated doxorubicin	0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of doxorubicinol	0, 2, 5, 11, 47, 71 hours after the first dose

Trial Locations

Locations (7)

Centre Oscar Lambret; 🇫🇷 Lille, France

CHU, Hôpital d'Enfants; 🇫🇷 Vandoeuvre les Nancy, France

CHU, Hôpital d'Enfants de la Timone; 🇫🇷 Marseille, France

Institut Gustave-Roussy; 🇫🇷 Villejuif, France

Institut Curie; 🇫🇷 Paris, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Unité d'Hémato-Oncologie, CHU, Hôpital des enfants; 🇫🇷 Toulouse, France