Know Cancer

forgot password

A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia

Phase 2
21 Years
Open (Enrolling)

Thank you

Trial Information

A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia

OBJECTIVES: I. Determine the response rate of patients with relapsed acute lymphocytic
leukemia, acute myeloid leukemia, or blastic phase chronic myelogenous leukemia treated with
oral topotecan. II. Determine the toxic effects and pharmacokinetics of this regimen in
these patients.

OUTLINE: Patients are stratified by disease type (acute lymphocytic leukemia vs acute
myeloid leukemia). Patients receive oral topotecan once daily on days 1-21. Courses repeat
every 28 days in the absence of blasts in the blood, M3 bone marrow, or unacceptable
toxicity. Patients are followed every 6 months until death.

PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study
within 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven relapsed acute lymphocytic leukemia, acute
myeloid leukemia, or blastic phase chronic myelogenous leukemia Refractory to conventional
therapy and other therapies of higher priority May have concurrent extramedullary relapse
except for testicular relapse or other extramedullary sites that may require concurrent

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: ECOG 0-2 Life expectancy:
At least 2 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0
times normal SGOT or SGPT less than 5 times normal Renal: Creatinine no greater than 1.5
times normal Other: Able to take oral liquid medication No GI neuropathy No other
condition that may affect absorption of drug No diabetes mellitus Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior bone marrow transplantation (BMT) or
peripheral blood stem cell transplantation (PBSCT) allowed and recovered At least 2 weeks
since prior cytokine therapy and recovered No concurrent immune modulator therapy No
concurrent cytokines including interleukin-11, interleukin-2, and epoetin alfa
Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and
recovered No more than 3 prior chemotherapy regimens No other concurrent chemotherapy
Endocrine therapy: No concurrent steroids Radiotherapy: No prior craniospinal radiotherapy
Prior total body irradiation allowed as part of BMT or PBSCT and recovered Concurrent
radiotherapy for localized painful lesions allowed Surgery: Not specified Other: No
concurrent metoclopramide or cisapride to maintain motility or gastric emptying No
concurrent H2 antagonists No concurrent proton pump inhibitors No concurrent antacids for
gastritis, gastroesophageal reflux, or ulcers (gastric or duodenal) No antacid therapy for
6 hours before and for 90 minutes after topotecan administration

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John S. Holcenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Children's Hospital


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • blastic phase chronic myelogenous leukemia
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Merit Care HospitalFargo, North Dakota  58122
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105