Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia
4 other identifiers
interventional
11
3 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 leukemia
Started Dec 1998
Typical duration for phase_2 leukemia
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2002
CompletedFirst Posted
Study publicly available on registry
April 23, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJuly 24, 2014
July 1, 2014
3.9 years
November 1, 1999
July 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Progression
For each stratum, this trial will determine topotecan to have insufficient activity for further investigation with probability 0.10 if the true response rate is 20%. For each stratum, this trial will determine topotecan to be of sufficient activity to warrant further investigation with probability 0.12 if the true response rate is 5%. Any patient who receives at least 21 days of therapy will be considered evaluable for response.
21 days
Study Arms (2)
Stratum 1 - Stage 1
EXPERIMENTALTopotecan hydrochloride (0.8 mg/m²/day) by mouth for 21 days. Bone marrow will be obtained on approximately Day 28 of Course 1 and 2 and in any course where the CBC suggests that a relapse has occurred. One additional course may be given if the blood is cleared of blasts and the bone marrow is M1, M2 or M3. The patient is off protocol therapy if blasts are still present in the blood and the marrow is M3. Subsequent courses of topotecan may be given only if the bone marrow after Course 2 is M1 or M2. If the bone marrow is M2 on Day 28 of any course, another bone marrow aspirate will be done at the end of the next course. If the patient is in CR, a bone marrow aspirate will be required only every other course unless the peripheral blood suggests that a relapse has occurred. Each subsequent course should begin within six weeks of the start of the previous course.
Stratum 2 - Stage 2
EXPERIMENTALTopotecan hydrochloride (0.8 mg/m²/day) by mouth for 21 days. Bone marrow will be obtained on approximately Day 28 of Course 1 and 2 and in any course where the CBC suggests that a relapse has occurred. One additional course may be given if the blood is cleared of blasts and the bone marrow is M1, M2 or M3. The patient is off protocol therapy if blasts are still present in the blood and the marrow is M3. Subsequent courses of topotecan may be given only if the bone marrow after Course 2 is M1 or M2. If the bone marrow is M2 on Day 28 of any course, another bone marrow aspirate will be done at the end of the next course. If the patient is in CR, a bone marrow aspirate will be required only every other course unless the peripheral blood suggests that a relapse has occurred. Each subsequent course should begin within six weeks of the start of the previous course.
Interventions
given by mouth
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (38)
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128, United States
Children's Hospital of Denver
Denver, Colorado, 80218, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696, United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
IWK Grace Health Centre
Halifax, Nova Scotia, B3J 3G9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John S. Holcenberg, MD
Seattle Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
April 23, 2004
Study Start
December 1, 1998
Primary Completion
November 1, 2002
Study Completion
September 1, 2006
Last Updated
July 24, 2014
Record last verified: 2014-07