Topotecan in Treating Children With Refractory Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002705
First received: November 1, 1999
Last updated: January 31, 2013
Last verified: May 2001
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: topotecan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 3
Study Start Date: April 1996
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
Drug: topotecan hydrochloride

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002705

  Show 31 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Wayne Lee Furman, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002705     History of Changes
Other Study ID Numbers: NCI-2012-01833, POG-9575, CDR0000064511
Study First Received: November 1, 1999
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
relapsing chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014