Topotecan in Treating Children With Refractory Leukemia
NCT ID: NCT00002705
Last Updated: 2013-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
1996-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
topotecan hydrochloride
Interventions
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topotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
-Histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists
PATIENT CHARACTERISTICS:
* Age: Under 21
* Performance status: ECOG 0-2
* Life expectancy: At least 8 weeks
* Adequate platelet count and hemoglobin required (transfusion allowed)
* Bilirubin no greater than 1.5 mg/dL
* AST or ALT no greater than 2 times normal
* Creatinine less than 1.5 mg/dL
* Adequate nutritional status, e.g. higher than third percentile weight for height
* Albumin at least 3 g/dL
* No severe uncontrolled infection
* No pregnant women
* Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
* At least 3 weeks since systemic chemotherapy (6 weeks since nitrosoureas)
* Recovered at least 3 months since bone marrow transplant (at least 6 months since total-body irradiation)
* No concurrent anticancer therapy
* No concurrent treatment studies
20 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Wayne Lee Furman, MD
Role: STUDY_CHAIR
St. Jude Children's Research Hospital
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 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
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, 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
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
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Memorial Mission Hospital
Asheville, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, 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
Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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References
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Furman WL, Stewart CF, Kirstein M, Kepner JL, Bernstein ML, Kung F, Vietti TJ, Steuber CP, Becton DL, Baruchel S, Pratt C. Protracted intermittent schedule of topotecan in children with refractory acute leukemia: a pediatric oncology group study. J Clin Oncol. 2002 Mar 15;20(6):1617-24. doi: 10.1200/JCO.2002.20.6.1617.
Other Identifiers
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POG-9575
Identifier Type: -
Identifier Source: secondary_id
CDR0000064511
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-01833
Identifier Type: -
Identifier Source: org_study_id
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