Clinical trial · Interventional
Topotecan in Treating Children With Refractory Leukemia
TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY
NCT00002705CI-TRIAL-00009256completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
- interventionNames
- Drug: topotecan hydrochloride
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFurman 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. PMID 11896112