TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY
topotecan hydrochloride
Hematologic Diseases+8
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: April 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: -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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 31 locations
University of Alabama Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama Comprehensive Cancer Center in Google MapsUniversity of Arkansas for Medical Sciences
Little Rock, United StatesUniversity of California San Diego Cancer Center
La Jolla, United StatesLucile Packard Children's Hospital at Stanford
Palo Alto, United States