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


Phase 2
12 Months
25 Years
Open (Enrolling)
Both
Rhabdomyosarcomas, Neoplasms, Connective and Soft Tissue, Ewing Tumor, Osteosarcomas, Neuroblastomas, Medulloblastomas

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Odile OBERLIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

NAVE-CYCLO

NCT ID:

NCT00180947

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Rhabdomyosarcomas
  • Neoplasms, Connective and Soft Tissue
  • Ewing Tumor
  • Osteosarcomas
  • Neuroblastomas
  • Medulloblastomas
  • Soft parts tissue
  • Neoplasms
  • Medulloblastoma
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Neoplasms, Connective and Soft Tissue
  • Sarcoma, Ewing's

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