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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

Interventions

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Doxorubicin

Intervention Type DRUG

Other Intervention Names

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MYOCET

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No