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

Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180947

Enrollment

210

Registered

2005-09-16

Start date

2003-06-30

Completion date

Unknown

Last updated

2006-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Soft parts tissue

Brief 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.

Interventions

DRUGVinorelbine, cyclofosfamide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 25 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To evaluate the hematologic tolerance of this association	—
To evaluate the pharmacokinetics of injectable Vinorelbine	—

Countries

France

Contacts

Primary ContactOdile OBERLIN, MD

oberlin@igr.fr33 1 42 11 41 74

Backup ContactAnnie REY

rey@igr.fr01 42 11 41 37

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026