Trials / Completed
CompletedNCT02861222
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- All
- Age
- 3 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxorubicin |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2016-08-10
- Last updated
- 2016-08-10
Locations
7 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02861222. Inclusion in this directory is not an endorsement.