NCT00003234

Vinorelbine in Treating Children With Recurrent or Refractory Cancers

A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.

Detailed description

OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children. OUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.

Conditions

• Brain and Central Nervous System Tumors
• Neuroblastoma
• Sarcoma

Interventions

Type	Name	Description
DRUG	vinorelbine tartrate

Timeline

• Start date: 1998-05-01
• Primary completion: 2006-03-01
• Completion: 2007-03-01
• First posted: 2003-10-28
• Last updated: 2014-07-28

Locations

228 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland