Clinical trial · Interventional
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
NCT00180947CI-TRIAL-00000427unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Tumor | Ewing Sarcoma | ALIAS | 0.90 |
| Medulloblastomas | Medulloblastoma | ALIAS | 0.90 |
| Neoplasms, Connective and Soft Tissue | Connective and Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neuroblastomas | Neuroblastoma | ALIAS | 0.90 |
| Osteosarcomas | Osteosarcoma | ALIAS | 0.90 |
| Rhabdomyosarcomas | Rhabdomyosarcoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine, cyclofosfamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
Secondary outcomes (2)
- measure
- To evaluate the hematologic tolerance of this association
- measure
- To evaluate the pharmacokinetics of injectable Vinorelbine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.