Topotecan in Treating Children With Refractory Leukemia
- Registration Number
- NCT00002705
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Phase I trial to study the effectiveness of topotecan in treating children with refractory leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
- Detailed Description
OBJECTIVES:
I. Describe the qualitative and quantitative toxic effects, including acute and chronic dose-limiting toxicity, cumulative toxicity, and time to recovery, in pediatric patients with refractory leukemia who are treated with a 30-minute daily infusion of topotecan (TOPO) for up to 12 consecutive days every 3 weeks.
II. Estimate the maximum tolerated dose of TOPO that results in tolerable, predictable, and reversible toxicity.
III. Determine the precautions and supportive therapy that should be used and the clinical and laboratory studies needed to monitor or alter therapy to prevent unacceptable toxicity in these patients.
IV. Observe any antileukemic effects that may occur during this phase I study in which duration of treatment is increased from 7 to 9 and then 12 days and TOPO doses are escalated.
V. Determine the recommended phase II pediatric dose of TOPO. VI. Characterize the pharmacokinetic parameters of TOPO and evaluate changes in these parameters with the first and last doses to determine whether there is drug accumulation.
VII. Correlate, if possible, these pharmacokinetic parameters with clinical response and toxicity.
OUTLINE:
Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I topotecan hydrochloride Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Clinique de Pediatrie
🇨🇭Geneva, Switzerland
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Memorial Mission Hospital
🇺🇸Asheville, North Carolina, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Boston Floating Hospital Infants and Children
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States