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This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine, cyclofosfamide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the hematologic tolerance of this association | ||
| To evaluate the pharmacokinetics of injectable Vinorelbine |
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Inclusion Criteria:
Age > 12 months and < 25 years
Measurable disease
Score of Lansky > 30 or World Health Organization (WHO) score < 2
Life expectancy > 2 months
Satisfactory hematologic conditions:
Creatinine < 1.5 of normal for age or clearance > 70 ml/min/1.73 m2
Normal hepatic function:
Absence of toxicity of bodies (Rank > 2 according to coding National Cancer Institute-Common Toxicity Criteria [NCI-CTC] version 2.0)
Absence of antecedent of hematuric cystitis to repetition
Written consent, signed by the patient or the two parents or holder(s) of the parental authority of the minor subjects
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Odile OBERLIN, MD | Contact | 33 1 42 11 41 74 | oberlin@igr.fr | |
| Annie REY | Contact | 01 42 11 41 37 | rey@igr.fr |
| Name | Affiliation | Role |
|---|---|---|
| Odile OBERLIN, MD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave-Roussy | Recruiting | Villejuif | 94800 | France |
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| ID | Term |
|---|---|
| D012208 | Rhabdomyosarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012512 | Sarcoma, Ewing |
| D012516 | Osteosarcoma |
| D009447 | Neuroblastoma |
| D008527 | Medulloblastoma |
| ID | Term |
|---|---|
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D005910 | Glioma |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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