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

Malignant Glioma Clinical Trial

— MYOCET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861222
• Other study ID #: 2009-017803-27
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2016
• Last updated: August 5, 2016
• Start date: October 2010
• Est. completion date: April 2013

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Drug:
• Doxorubicin

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	CHU, Hôpital d'Enfants de la Timone	Marseille
France	Institut Curie	Paris
France	Unité d'Hémato-Oncologie, CHU, Hôpital des enfants	Toulouse
France	CHU, Hôpital d'Enfants	Vandoeuvre les Nancy
France	Institut Gustave-Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General health evaluation	NCI-CTC scale, version 3, appendix 6	From day 21 post-dose	Yes
Primary	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	Yes
Primary	Complete blood count (platelet included)		2 times/week from day 0	Yes
Primary	ALAT/ASAT measurement		From day 21 post-dose	Yes
Primary	Bilirubin test		From day 21 post-dose	Yes
Primary	Prothrombin test		From day 21 post-dose	Yes
Primary	Fibrin measurement		From day 21 post-dose	Yes
Primary	Partial thromboplastin time test		From day 21 post-dose	Yes
Primary	Creatinine blood test		From day 21 post-dose	Yes
Primary	Analysis of the electrolyte composition of the blood		From day 21 post-dose	Yes
Primary	Blood urea analysis		From day 21 post-dose	Yes
Primary	Glycemia analysis		From day 21 post-dose	Yes
Primary	Calcemia analysis		From day 21 post-dose	Yes
Primary	Protidaemia analysis		From day 21 post-dose	Yes
Primary	Normality of ECG		From day 21 post-dose	Yes
Primary	Echocardiography with analysis of ventricular ejection and shortening fractions		From day 21 post-dose	Yes
Secondary	Measure of initial tumors with MRI		from day 42, after each 2 treatments	No
Secondary	Antitumoral activity (radiological criteria of SIOP protocol)		from day 42, after each 2 treatments	No
Secondary	Plasma measurement of free doxorubicin		0, 2, 5, 11, 47, 71 hours after the first dose	No
Secondary	Plasma measurement of encapsulated doxorubicin		0, 2, 5, 11, 47, 71 hours after the first dose	No
Secondary	Plasma measurement of doxorubicinol		0, 2, 5, 11, 47, 71 hours after the first dose	No