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.
Interventional
Primary Purpose: Treatment
John S. Holcenberg, MD
Study Chair
Seattle Children's Hospital
United States: Federal Government
CDR0000066850
NCT00003735
December 1998
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
Veterans Affairs Medical Center - Fargo | Fargo, North Dakota 58102 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Long Beach Memorial Medical Center | Long Beach, California 90806 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's Hospital of Denver | Denver, Colorado 80218 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
Children's Hospital Medical Center - Cincinnati | Cincinnati, Ohio 45229-3039 |
Children's Hospital of Columbus | Columbus, Ohio 43205-2696 |
Doernbecher Children's Hospital | Portland, Oregon 97201-3098 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |