Malignant GliomaPhase 1MYOCETNCT02861222
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
A Phase 1 study testing Doxorubicin in people with Malignant Glioma, run by Central Hospital, Nancy, France at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 7 sitesFrance
- Study dates
- Oct 2010to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 19Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon
CHU, Hôpital d'Enfants de la Timone
Marseille
Institut Curie
Paris
Unité d'Hémato-Oncologie, CHU, Hôpital des enfants
Toulouse
CHU, Hôpital d'Enfants
Vandœuvre-lès-Nancy
Institut Gustave-Roussy
Villejuif
About this study
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
- Malignant Glioma
- Being tested
- Doxorubicin
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called MYOCET
| Study group | Role | What they receive |
|---|---|---|
| MYOCET | Experimental | 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. Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
General health evaluation
NCI-CTC scale, version 3, appendix 6
Measured: 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
Measured: From day 21 post-dose
Complete blood count (platelet included)
Measured: 2 times/week from day 0
ALAT/ASAT measurement
Measured: From day 21 post-dose
Bilirubin test
Measured: From day 21 post-dose
Prothrombin test
Measured: From day 21 post-dose
Fibrin measurement
Measured: From day 21 post-dose
Partial thromboplastin time test
Measured: From day 21 post-dose
Creatinine blood test
Measured: From day 21 post-dose
Analysis of the electrolyte composition of the blood
Measured: From day 21 post-dose
Blood urea analysis
Measured: From day 21 post-dose
Glycemia analysis
Measured: From day 21 post-dose
Calcemia analysis
Measured: From day 21 post-dose
Protidaemia analysis
Measured: From day 21 post-dose
Normality of ECG
Measured: From day 21 post-dose
Echocardiography with analysis of ventricular ejection and shortening fractions
Measured: From day 21 post-dose
Secondary outcomes (5)
Measure of initial tumors with MRI
Measured: from day 42, after each 2 treatments
Antitumoral activity (radiological criteria of SIOP protocol)
Measured: from day 42, after each 2 treatments
Plasma measurement of free doxorubicin
Measured: 0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of encapsulated doxorubicin
Measured: 0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of doxorubicinol
Measured: 0, 2, 5, 11, 47, 71 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Chastagner, Principal investigator, Service d'Hémato-Oncologie pédiatrique, Hôpital d'Enfants, CHU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861222
- Sponsor's protocol ID
- 2009-017803-27
- Other IDs
- 2009
- Acronym
- MYOCET
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
- ClinicalTrials.gov ID
- NCT02861222
- Acronym / sponsor ID
- MYOCET / 2009-017803-27
- Conditions
- Malignant Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MYOCET | Experimental | Drug: Doxorubicin2 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinAlso: MYOCET | Drug | MYOCET |
Primary outcome
General health evaluation
Time frame: From day 21 post-dose
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
Time frame: From day 21 post-dose
Complete blood count (platelet included)
Time frame: 2 times/week from day 0
ALAT/ASAT measurement
Time frame: From day 21 post-dose
Bilirubin test
Time frame: From day 21 post-dose
Prothrombin test
Time frame: From day 21 post-dose
Fibrin measurement
Time frame: From day 21 post-dose
Partial thromboplastin time test
Time frame: From day 21 post-dose
Creatinine blood test
Time frame: From day 21 post-dose
Analysis of the electrolyte composition of the blood
Time frame: From day 21 post-dose
Blood urea analysis
Time frame: From day 21 post-dose
Glycemia analysis
Time frame: From day 21 post-dose
Calcemia analysis
Time frame: From day 21 post-dose
Protidaemia analysis
Time frame: From day 21 post-dose
Normality of ECG
Time frame: From day 21 post-dose
Echocardiography with analysis of ventricular ejection and shortening fractions
Time frame: From day 21 post-dose
5 secondary outcomes
Measure of initial tumors with MRI
Time frame: from day 42, after each 2 treatments
Antitumoral activity (radiological criteria of SIOP protocol)
Time frame: from day 42, after each 2 treatments
Plasma measurement of free doxorubicin
Time frame: 0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of encapsulated doxorubicin
Time frame: 0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of doxorubicinol
Time frame: 0, 2, 5, 11, 47, 71 hours after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Chastagner principal investigator
Service d'Hémato-Oncologie pédiatrique, Hôpital d'Enfants, CHU Nancy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxorubicin in people with Malignant Glioma, run by Central Hospital, Nancy, France at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General health evaluation (time frame: From day 21 post-dose). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.