Spots Global Cancer Trial Database for Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
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Trial Identification
Brief Title: Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
Official Title: A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia
Study ID: NCT00003735
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of topotecan in treating children who have relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous leukemia.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Long Beach Memorial Medical Center, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Children's Hospital of Denver, Denver, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Fargo, Fargo, North Dakota, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Children's Hospital of Columbus, Columbus, Ohio, United States
Doernbecher Children's Hospital, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Vanderbilt Cancer Center, Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
IWK Grace Health Centre, Halifax, Nova Scotia, Canada
Contact Details
Name: John S. Holcenberg, MD
Affiliation: Seattle Children's Hospital
Role: STUDY_CHAIR
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