Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
MYOCET
1 other identifier
interventional
13
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2010
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedAugust 10, 2016
August 1, 2016
2.5 years
August 3, 2016
August 5, 2016
Conditions
Outcome Measures
Primary Outcomes (16)
General health evaluation
NCI-CTC scale, version 3, appendix 6
From day 21 post-dose
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
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
Calcemia analysis
From day 21 post-dose
Protidaemia analysis
From day 21 post-dose
Normality of ECG
From day 21 post-dose
Echocardiography with analysis of ventricular ejection and shortening fractions
From day 21 post-dose
Secondary Outcomes (5)
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
Study Arms (1)
MYOCET
EXPERIMENTAL2 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
Vandœuvre-lès-Nancy, France
Institut Gustave-Roussy
Villejuif, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pascal Chastagner
Service d'Hémato-Oncologie pédiatrique, Hôpital d'Enfants, CHU Nancy
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 10, 2016
Study Start
October 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 10, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share