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Topotecan in Treating Children With Refractory Leukemia

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00002705
Collaborator
(none)
3
Enrollment
31
Locations
1
Arm
0.1
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: topotecan hydrochloride
 Phase 1

Detailed Description

OBJECTIVES:

  1. 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.

  2. Estimate the maximum tolerated dose of TOPO that results in tolerable, predictable, and reversible toxicity.

  3. 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.

  4. 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.

  5. 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.

  6. Correlate, if possible, these pharmacokinetic parameters with clinical response and toxicity.

OUTLINE:

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

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY
Study Start Date :
Apr 1, 1996
Actual Primary Completion Date :
Jan 1, 2001

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

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

Drug: topotecan hydrochloride

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 20 Years
    Sexes Eligible for Study:
    All
    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

    • 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

    Locations

    Site City State Country Postal Code
    1 University of Alabama Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    3 University of California San Diego Cancer Center La Jolla California United States 92093-0658
    4 Lucile Packard Children's Hospital at Stanford Palo Alto California United States 94304
    5 Shands Hospital and Clinics, University of Florida Gainesville Florida United States 32610-100277
    6 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    7 Children's Memorial Hospital, Chicago Chicago Illinois United States 60614
    8 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    9 Via Christi Regional Medical Center Wichita Kansas United States 67214
    10 MBCCOP - LSU Medical Center New Orleans Louisiana United States 70112
    11 Johns Hopkins Oncology Center Baltimore Maryland United States 21287
    12 Boston Floating Hospital Infants and Children Boston Massachusetts United States 02111
    13 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    14 Children's Hospital of Michigan Detroit Michigan United States 48201
    15 Washington University School of Medicine Saint Louis Missouri United States 63110
    16 Hackensack University Medical Center Hackensack New Jersey United States 07601
    17 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    18 State University of New York - Upstate Medical University Syracuse New York United States 13210
    19 Memorial Mission Hospital Asheville North Carolina United States 28801
    20 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    21 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105-2794
    22 Medical City Dallas Hospital Dallas Texas United States 75230
    23 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    24 Baylor College of Medicine Houston Texas United States 77030
    25 San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas United States 78236-5300
    26 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    27 Midwest Children's Cancer Center Milwaukee Wisconsin United States 53226
    28 Montreal Children's Hospital Montreal Quebec Canada H3H 1P3
    29 Hopital Sainte Justine Montreal Quebec Canada H3T 1C5
    30 University of Puerto Rico School of Medicine Medical Sciences Campus San Juan Puerto Rico 00936-5067
    31 Clinique de Pediatrie Geneva Switzerland 1211

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Wayne Lee Furman, MD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00002705
    Other Study ID Numbers:
    • NCI-2012-01833
    • POG-9575
    • CDR0000064511
    First Posted:
    Jul 1, 2004
    Last Update Posted:
    Feb 1, 2013
    Last Verified:
    May 1, 2001
    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
    Topotecan

    Study Results

    No Results Posted as of Feb 1, 2013