Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Treatments:
Vinblastine
Vinorelbine
Criteria
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