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

Gustave Roussy, Cancer Campus, Grand Paris210 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Rhabdomyosarcomas Neoplasms, Connective and Soft Tissue Ewing Tumor Osteosarcomas Neuroblastomas Medulloblastomas

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

To evaluate the hematologic tolerance of this association

To evaluate the pharmacokinetics of injectable Vinorelbine

Central Contacts

Odile OBERLIN, MD

CONTACT

33 1 42 11 41 74 oberlin@igr.fr

Annie REY