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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

January 31, 2013

Start Date ^ICMJE

April 1996

Primary Completion Date

January 2001 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00002705 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Topotecan in Treating Children With Refractory Leukemia

Official Title ^ICMJE

TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Drug: topotecan hydrochloride

Study Arm (s)

Experimental: Arm I

Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.

Intervention: Drug: topotecan hydrochloride

Publications *

Furman 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

January 2001 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 20 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Puerto Rico, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00002705

Other Study ID Numbers ^ICMJE

NCI-2012-01833, POG-9575, CDR0000064511

Has Data Monitoring Committee

Not Provided

Responsible Party

National Cancer Institute (NCI)

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Wayne Lee Furman, MD

St. Jude Children's Research Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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