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Sponsors and Collaborators: |
Pediatric Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002705 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan in treating children with refractory leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: topotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY |
Study Start Date: | April 1996 |
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.
PROJECTED ACCRUAL: At least 3 evaluable patients/dose will be studied.
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 Hematopoietic: Adequate platelet count and hemoglobin required (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL AST or ALT no greater than 2 times normal Renal: Creatinine less than 1.5 mg/dL Other: 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) and 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 Chair: | Wayne Lee Furman, MD | St. Jude Children's Research Hospital |
Study ID Numbers: | CDR0000064511, POG-9575 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002705 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia relapsing chronic myelogenous leukemia |
Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence Acute Myeloid Leukemia, Childhood |
Leukemia Acute Myelocytic Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Topotecan Acute Lymphoblastic Leukemia |
Leukemia Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Topotecan Pharmacologic Actions |