Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2002-01-31
2005-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
NCT00015847
Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
NCT00052949
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
NCT00054431
Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
NCT00025415
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
NCT00038610
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with recurrent Philadelphia chromosome-positive leukemia.
* Characterize the pharmacokinetic behavior of this drug in this patient population.
* Determine preliminarily the antileukemic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral imatinib mesylate (STI571) once daily for 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study within 3.5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
260 mg/m2 imatinib mesylate (ST571)
imatinib mesylate
340 mg/m2 imatinib mesylate (ST571)
imatinib mesylate
440 mg/m2 imatinib mesylate (ST571)
imatinib mesylate
570 mg/m2 imatinib mesylate (ST571)
imatinib mesylate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
imatinib mesylate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Recurrent Philadelphia (Ph) chromosome-positive leukemia
* Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR
* Chronic myelogenous leukemia with resistance to interferon alfa with any of the following:
* WBC at least 20,000/mm\^3 after at least 3 months of interferon therapy
* At least 100% increase in WBC to at least 20,000/mm\^3 confirmed over 2 weeks while receiving interferon alfa
* At least 66% Ph chromosome-positive cells after 1 year of interferon therapy
* At least 30% increase in number of Ph chromosome-positive cells after an interferon-induced response while continuing interferon therapy
PATIENT CHARACTERISTICS:
Age:
* Under 22
Performance status:
* Karnofsky 50-100% if over 10 years of age OR
* Lansky 50-100% if 10 years of age and under
Life expectancy:
* At least 8 weeks
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGPT less than 3 times normal
* Albumin greater than 2 g/dL
Renal:
* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host disease
* No seizure disorder if on anticonvulsants
* No uncontrolled infection
* No CNS toxicity greater than grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 1 week since prior biologic therapy and recovered
* At least 3 months since prior stem cell transplantation (SCT)
* At least 1 week since prior growth factors
* At least 1 week since prior interferon alfa
Chemotherapy:
* Recovered from prior chemotherapy
* At least 6 weeks since prior busulfan and nitrosoureas
* At least 2 weeks since prior homoharringtonine
* At least 1 week since low-dose cytarabine
* At least 2 weeks since prior moderate-dose cytarabine
* At least 4 weeks since prior high-dose cytarabine
* At least 3 weeks since all other prior cytotoxic chemotherapies
* No prior hydroxyurea
Endocrine therapy:
* Must be on a stable dose of steroids if received prior allogeneic SCT
Radiotherapy:
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior craniospinal radiotherapy
* At least 6 months since prior radiotherapy to 50% or more of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent investigational agents
* No concurrent anticonvulsants
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Champagne, MD
Role: STUDY_CHAIR
Hopital Sainte Justine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of South Alabama Medical Center
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Oakland
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Children's Hospital San Diego
San Diego, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
Childhood Hematology/Oncology Associates
Denver, Colorado, United States
Presbyterian-St Luke's Medical Center
Denver, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Alfred I. Dupont Institute
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami-Jackson Memorial Hospital
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Nemours Children's Clinic-Orlando
Orlando, Florida, United States
Sacred Heart Children's Hospital
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Tampa Children's Hospital
Tampa, Florida, United States
St. Mary's Hospital
West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Memorial Health University Medical Center, Inc.
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Mountain States Tumor Institute
Boise, Idaho, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Hope Children's Hospital
Oak Lawn, Illinois, United States
Lutheran General Hospital
Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Raymond Blank Memorial Hospital for Children
Des Moines, Iowa, United States
John Stoddard Cancer Center
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Wesley Medical Center
Wichita, Kansas, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Floating Hospital for Children
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Children's Hospital of Omaha
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
Atlantic Health System
Summit, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
Brooklyn Hospital Center
Brooklyn, New York, United States
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia Presbyterian Hospital
New York, New York, United States
James P. Wilmot Cancer Center
Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Saint Joseph's Health System
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Dakota Cancer Institute
Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Forum Health-Tod Childrens Hospital
Youngstown, Ohio, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sioux Valley Hospital
Sioux Falls, South Dakota, United States
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States
Children's Hospital of Austin
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Methodist Health Care System
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Vermont Cancer Center
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Carilion Medical Center for Children
Roanoke, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Cooperative
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Mary Bridge Children's Health Center
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University - Charleston
Charleston, West Virginia, United States
Cabell-Huntington Hospital, Inc
Huntington, West Virginia, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Sydney Children's Hospital
Randwick, New South Wales, Australia
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Laval University Medical Center
Sainte-Foy, Quebec, Canada
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
Starship Children's Hospital
Auckland, , New Zealand
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
San Jorge Childrens Hospital
Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva, , Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Champagne MA, Capdeville R, Krailo M, Qu W, Peng B, Rosamilia M, Therrien M, Zoellner U, Blaney SM, Bernstein M; Children's Oncology Group phase 1 study. Imatinib mesylate (STI571) for treatment of children with Philadelphia chromosome-positive leukemia: results from a Children's Oncology Group phase 1 study. Blood. 2004 Nov 1;104(9):2655-60. doi: 10.1182/blood-2003-09-3032. Epub 2004 Jul 1.
Champagne MA, Hershon L, Rosamilia M, et al.: STI571 in the Treatment of Pediatric Philadelphia (Ph+) Chromosome-Positive Leukemia: A Children's Oncology Group Phase 1 Study (P-9973). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1466, 2001.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COG-P9973
Identifier Type: OTHER
Identifier Source: secondary_id
POG-9973
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-P9973
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067616
Identifier Type: OTHER
Identifier Source: secondary_id
P9973
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.