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

Primary Purpose

Malignant Glioma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Doxorubicin
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Glioma

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Oscar Lambret
  • Centre Léon Bérard
  • CHU, Hôpital d'Enfants de la Timone
  • Institut Curie
  • Unité d'Hémato-Oncologie, CHU, Hôpital des enfants
  • CHU, Hôpital d'Enfants
  • Institut Gustave-Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MYOCET

Arm 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.

Outcomes

Primary Outcome Measures

General health evaluation
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
Complete blood count (platelet included)
ALAT/ASAT measurement
Bilirubin test
Prothrombin test
Fibrin measurement
Partial thromboplastin time test
Creatinine blood test
Analysis of the electrolyte composition of the blood
Blood urea analysis
Glycemia analysis
Calcemia analysis
Protidaemia analysis
Normality of ECG
Echocardiography with analysis of ventricular ejection and shortening fractions

Secondary Outcome Measures

Measure of initial tumors with MRI
Antitumoral activity (radiological criteria of SIOP protocol)
Plasma measurement of free doxorubicin
Plasma measurement of encapsulated doxorubicin
Plasma measurement of doxorubicinol

Full Information

First Posted
August 3, 2016
Last Updated
August 5, 2016
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02861222
Brief Title
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
Acronym
MYOCET
Official Title
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MYOCET
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
MYOCET
Primary Outcome Measure Information:
Title
General health evaluation
Description
NCI-CTC scale, version 3, appendix 6
Time Frame
From day 21 post-dose
Title
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
Title
Complete blood count (platelet included)
Time Frame
2 times/week from day 0
Title
ALAT/ASAT measurement
Time Frame
From day 21 post-dose
Title
Bilirubin test
Time Frame
From day 21 post-dose
Title
Prothrombin test
Time Frame
From day 21 post-dose
Title
Fibrin measurement
Time Frame
From day 21 post-dose
Title
Partial thromboplastin time test
Time Frame
From day 21 post-dose
Title
Creatinine blood test
Time Frame
From day 21 post-dose
Title
Analysis of the electrolyte composition of the blood
Time Frame
From day 21 post-dose
Title
Blood urea analysis
Time Frame
From day 21 post-dose
Title
Glycemia analysis
Time Frame
From day 21 post-dose
Title
Calcemia analysis
Time Frame
From day 21 post-dose
Title
Protidaemia analysis
Time Frame
From day 21 post-dose
Title
Normality of ECG
Time Frame
From day 21 post-dose
Title
Echocardiography with analysis of ventricular ejection and shortening fractions
Time Frame
From day 21 post-dose
Secondary Outcome Measure Information:
Title
Measure of initial tumors with MRI
Time Frame
from day 42, after each 2 treatments
Title
Antitumoral activity (radiological criteria of SIOP protocol)
Time Frame
from day 42, after each 2 treatments
Title
Plasma measurement of free doxorubicin
Time Frame
0, 2, 5, 11, 47, 71 hours after the first dose
Title
Plasma measurement of encapsulated doxorubicin
Time Frame
0, 2, 5, 11, 47, 71 hours after the first dose
Title
Plasma measurement of doxorubicinol
Time Frame
0, 2, 5, 11, 47, 71 hours after the first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Chastagner
Organizational Affiliation
Service d'Hémato-Oncologie pédiatrique, Hôpital d'Enfants, CHU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
CHU, Hôpital d'Enfants de la Timone
City
Marseille
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Unité d'Hémato-Oncologie, CHU, Hôpital des enfants
City
Toulouse
Country
France
Facility Name
CHU, Hôpital d'Enfants
City
Vandoeuvre les Nancy
Country
France
Facility Name
Institut Gustave-Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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