Vinorelbine in Treating Children With Recurrent or Refractory Cancers

Phase 2

Completed

• Conditions: Neuroblastoma; Sarcoma; Brain and Central Nervous System Tumors
• Interventions: Drug: vinorelbine tartrate

• Registration Number: NCT00003234
• Lead Sponsor: Children's Oncology Group

Brief 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.

Study Timeline

• Study Start: 1998-05
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-10-27
• Study First Posted: 2003-10-28
• Primary Completion: 2006-03
• Study Completion: 2007-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stratum 2 - CNS Tumors	vinorelbine tartrate	See detailed description.
Stratum 1 - Soft Tissue Sarcoma	vinorelbine tartrate	See detailed description.
Stratum 3 - Neuroblastoma	vinorelbine tartrate	See detailed description.

Primary Outcome Measures

Name	Time	Method
Disease progression

Trial Locations

Locations (227)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of South Alabama Medical Center; 🇺🇸 Mobile, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Southern California Permanente Medical Group; 🇺🇸 Downey, California, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Jonathan Jaques Children's Cancer Center; 🇺🇸 Long Beach, California, United States

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