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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00180947 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
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Scientific title:
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Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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210 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00180947 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Odile OBERLIN, MD |
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Address:
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Telephone:
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33 1 42 11 41 74 |
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Email:
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oberlin@igr.fr |
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Affiliation:
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Name:
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Odile OBERLIN, MD |
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Address:
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Telephone:
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33 1 42 11 41 74 |
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Email:
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oberlin@igr.fr |
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Affiliation:
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Name:
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Odile OBERLIN, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Gustave Roussy |
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Key inclusion & exclusion criteria
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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:
- 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
Exclusion Criteria:
- Does not satisfy the criteria of eligibility
Age minimum:
12 Months
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ewing Tumor
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Medulloblastomas
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Neoplasms, Connective and Soft Tissue
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Neuroblastomas
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Osteosarcomas
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Rhabdomyosarcomas
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Intervention(s)
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Drug: Vinorelbine, cyclofosfamide
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Primary Outcome(s)
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To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
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Secondary Outcome(s)
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To evaluate the hematologic tolerance of this association
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To evaluate the pharmacokinetics of injectable Vinorelbine
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Secondary ID(s)
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NAVE-CYCLO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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