Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse

Overview

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.

Full Title of Study: “Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Interventions

• Drug: Vinorelbine, cyclofosfamide

Clinical Trial Outcome Measures

Primary Measures

• To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse

Secondary Measures

• To evaluate the hematologic tolerance of this association
• To evaluate the pharmacokinetics of injectable Vinorelbine

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Gustave Roussy, Cancer Campus, Grand Paris
• Overall Official(s)
  • Odile OBERLIN, MD, Principal Investigator, Gustave Roussy, Cancer Campus, Grand Paris
• Overall Contact(s)
  • Odile OBERLIN, MD, 33 1 42 11 41 74, oberlin@igr.fr