Know Cancer

or
forgot password

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


Phase 1
N/A
20 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Wayne Lee Furman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01833

NCT ID:

NCT00002705

Start Date:

April 1996

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • relapsing chronic myelogenous leukemia
  • Leukemia

Name

Location

Baylor College of MedicineHouston, Texas  77030
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Washington University School of MedicineSaint Louis, Missouri  63110
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Children's Hospital of MichiganDetroit, Michigan  48201
Memorial Mission HospitalAsheville, North Carolina  28801
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Hackensack University Medical CenterHackensack, New Jersey  07601
Via Christi Regional Medical CenterWichita, Kansas  67214
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Memorial Hospital, ChicagoChicago, Illinois  60614