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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00180947
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Rhabdomyosarcomas
Neoplasms, Connective and Soft Tissue
Ewing Tumor
Osteosarcomas
Neuroblastomas
Medulloblastomas
Drug: Vinorelbine, cyclofosfamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse

Secondary Outcome Measures:
  • To evaluate the hematologic tolerance of this association
  • To evaluate the pharmacokinetics of injectable Vinorelbine

Estimated Enrollment: 210
Study Start Date: June 2003
  Eligibility

Ages Eligible for Study:   12 Months to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180947

Contacts
Contact: Odile OBERLIN, MD 33 1 42 11 41 74 oberlin@igr.fr
Contact: Annie REY 01 42 11 41 37 rey@igr.fr

Locations
France
Institut Gustave-Roussy Recruiting
Villejuif, France, 94800
Contact: Odile OBERLIN, MD    33 1 42 11 41 74    oberlin@igr.fr   
Contact: Annie REY    33 1 42 11 41 37    rey@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Odile OBERLIN, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180947     History of Changes
Other Study ID Numbers: NAVE-CYCLO
Study First Received: September 13, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Soft parts tissue

Additional relevant MeSH terms:
Medulloblastoma
Neoplasms, Connective and Soft Tissue
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Glioma
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Muscle Tissue
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Vinorelbine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014