Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
- Registration Number
- NCT00006462
- 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 gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.
- Detailed Description
OBJECTIVES:
* Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine.
* Assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia).
Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Relapsed acute lymphoblastic and acute Myelogenous leukemia gemcitabine hydrochloride Gemcitabine hydrochloride will be given as 10 mg/m2/min x 360 minutes weekly for three weeks. After a one-week rest period it may be repeated in patients without progressive disease or limiting toxicity.
- Primary Outcome Measures
Name Time Method Determine the response rate to Gemcitabine To determine the response rate to Gemcitabine administered as 10 mg/m2/min x 360 minutes weekly for 3 weeks in patients with relapsed acute lymphoblastic and acute myelogenous leukemia.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (224)
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
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 Medical Center
🇺🇸Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center
🇺🇸Long Beach, California, United States
Scroll for more (214 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States