Neoplasms, Connective and Soft Tissue Clinical Trial
Official title:
Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Months to 25 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Institut Gustave-Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Gustave Roussy, Cancer Campus, Grand Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse | |||
Secondary | To evaluate the hematologic tolerance of this association | |||
Secondary | To evaluate the pharmacokinetics of injectable Vinorelbine |
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