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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02861222
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: Doxorubicin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
Study Start Date : October 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MYOCET
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.
Drug: Doxorubicin
Other Name: MYOCET

Primary Outcome Measures :
  1. General health evaluation [ Time Frame: From day 21 post-dose ]
    NCI-CTC scale, version 3, appendix 6

  2. 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 [ Time Frame: From day 21 post-dose ]
  3. Complete blood count (platelet included) [ Time Frame: 2 times/week from day 0 ]
  4. ALAT/ASAT measurement [ Time Frame: From day 21 post-dose ]
  5. Bilirubin test [ Time Frame: From day 21 post-dose ]
  6. Prothrombin test [ Time Frame: From day 21 post-dose ]
  7. Fibrin measurement [ Time Frame: From day 21 post-dose ]
  8. Partial thromboplastin time test [ Time Frame: From day 21 post-dose ]
  9. Creatinine blood test [ Time Frame: From day 21 post-dose ]
  10. Analysis of the electrolyte composition of the blood [ Time Frame: From day 21 post-dose ]
  11. Blood urea analysis [ Time Frame: From day 21 post-dose ]
  12. Glycemia analysis [ Time Frame: From day 21 post-dose ]
  13. Calcemia analysis [ Time Frame: From day 21 post-dose ]
  14. Protidaemia analysis [ Time Frame: From day 21 post-dose ]
  15. Normality of ECG [ Time Frame: From day 21 post-dose ]
  16. Echocardiography with analysis of ventricular ejection and shortening fractions [ Time Frame: From day 21 post-dose ]

Secondary Outcome Measures :
  1. Measure of initial tumors with MRI [ Time Frame: from day 42, after each 2 treatments ]
  2. Antitumoral activity (radiological criteria of SIOP protocol) [ Time Frame: from day 42, after each 2 treatments ]
  3. Plasma measurement of free doxorubicin [ Time Frame: 0, 2, 5, 11, 47, 71 hours after the first dose ]
  4. Plasma measurement of encapsulated doxorubicin [ Time Frame: 0, 2, 5, 11, 47, 71 hours after the first dose ]
  5. Plasma measurement of doxorubicinol [ Time Frame: 0, 2, 5, 11, 47, 71 hours after the first dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02861222

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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, France
Sponsors and Collaborators
Central Hospital, Nancy, France
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Principal Investigator: Pascal Chastagner Service d'Hémato-Oncologie pédiatrique, Hôpital d'Enfants, CHU Nancy
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Responsible Party: Central Hospital, Nancy, France Identifier: NCT02861222    
Other Study ID Numbers: 2009-017803-27
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action