Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
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ClinicalTrials.gov Identifier: NCT00180947
Recruitment Status : Unknown
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris. Recruitment status was: Recruiting
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.
Condition or disease
RhabdomyosarcomasNeoplasms, Connective and Soft TissueEwing TumorOsteosarcomasNeuroblastomasMedulloblastomas
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Layout table for eligibility information
Ages Eligible for Study:
12 Months to 25 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age > 12 months and < 25 years
Score of Lansky > 30 or World Health Organization (WHO) score < 2
Life expectancy > 2 months
Satisfactory hematologic conditions:
Polynuclear neutrophiles > 1 X 10^9/l.
Platelets > 100 X 10^9/l or > 50 X 10^9 in the event of medullary invasion.
Creatinine < 1.5 of normal for age or clearance > 70 ml/min/1.73 m2
Normal hepatic function:
Bilirubin < 3 N
ASAT and ALAT < 2,5 N).
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