A Phase 1 interventional study of topotecan hydrochloride in Leukemia, sponsored by National Cancer Institute (NCI). Completed at 31 sites in 4 countries. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2013-02-01.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 3 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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DISEASE CHARACTERISTICS:
-Histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
Drug: topotecan hydrochloride
This study is completed, as verified in May 2001. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)