Children and teenagers with refractory/relapsing solid tumor
Conditions
Brief summary
Maximum tolerated dose (MTD) assessed over the first two treatment cycles (D1 to D56) according to the NCI-CTC v5.0 scale and defined as follows: - Grade 3 or 4 neutropenia requiring treatment deferral of more than 7 days - Grade 3 or 4 thrombocytopenia requiring transfusions for more than 7 days - Grade 3 or 4 non-hematological toxicity, with the exception of : - nausea and vomiting - grade 3 fever, - grade 3 liver toxicity reversible after 14 days
Detailed description
Tolerance judged using NCI-CTC v5.0 scale, PK performed by liquid chromatography coupled with either mass spectrometry (LCMSMS) or UV detection, Efficacy: Progression-free survival 2, 4, 6, 12, 18 and 24 months of treatmentand overall survival after 6, 12, 18 and 24 months of treatment, and response rate according to RECIST, SIOPEN or WHO criteria. PFS will be calculated from study entry to the date of progression or death (if related to tumor or treatment toxicities). Overall survival will be calculated from study entry to date of death.
Interventions
DRUGHEMANGIOL 3.75 mg/mL oral solution
DRUGPropranolol Teva 40 mg
DRUGcomprimé sécable
DRUGNAVELBINE 20 mg
DRUGcapsule molle
DRUGNAVELBINE 30 mg
Sponsors
Centre Hospitalier Regional De Marseille
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) assessed over the first two treatment cycles (D1 to D56) according to the NCI-CTC v5.0 scale and defined as follows: - Grade 3 or 4 neutropenia requiring treatment deferral of more than 7 days - Grade 3 or 4 thrombocytopenia requiring transfusions for more than 7 days - Grade 3 or 4 non-hematological toxicity, with the exception of : - nausea and vomiting - grade 3 fever, - grade 3 liver toxicity reversible after 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance judged using NCI-CTC v5.0 scale, PK performed by liquid chromatography coupled with either mass spectrometry (LCMSMS) or UV detection, Efficacy: Progression-free survival 2, 4, 6, 12, 18 and 24 months of treatmentand overall survival after 6, 12, 18 and 24 months of treatment, and response rate according to RECIST, SIOPEN or WHO criteria. PFS will be calculated from study entry to the date of progression or death (if related to tumor or treatment toxicities). Overall survival will be calculated from study entry to date of death. | — |
Countries
France
Outcome results
None listed