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A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia.
OBJECTIVES: * Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 1 year.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Start Date
August 1, 2002
Primary Completion Date
March 1, 2006
Completion Date
September 1, 2006
Last Updated
August 8, 2014
12
ACTUAL participants
docetaxel
DRUG
Lead Sponsor
Children's Oncology Group
Collaborators
NCT07388563
NCT00106925
Data Source & Attribution
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