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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia  Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
For Condition: Acute Myeloid Leukemia
Status: No longer recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia.
Details: OBJECTIVES: - Determine the complete response rate in children with primary refractory or recurrent acute myeloid leukemia (AML) or secondary AML treated with idarubicin and cladribine. (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02) - Compare the remission reinduction rates in children who relapse at 1 year or earlier vs more than 1 year from time of initial remission. - Determine the toxic effects of this regimen in this patient population. OUTLINE: Patients are stratified according to disease characteristics (primary or secondary acute myeloid leukemia (AML) with first untreated relapse vs primary refractory AML). (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02) Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 51-102 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Acute myeloid leukemia (AML) (FAB M0-M7) - Secondary AML in first relapse (Secondary AML stratum closed as of 04/02/02) - AML in primary induction failure (Refractory AML stratum closed as of 04/03/01) - Myelodysplastic syndromes (MDS) (not related to Down syndrome) (MDS stratum closed as of 04/03/01) - Extramedullary disease allowed - Relapse more than 6 months after allogeneic or autologous bone marrow transplantation allowed PATIENT CHARACTERISTICS: Age: - Under 21 at diagnosis Performance status: - Karnofsky 50-100% (over 10 years) - Lansky 50-100% (10 years and under) Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 1.5 mg/dL - ALT less than 3 times normal Renal: - Creatinine less than 2 times normal Cardiovascular: - Shortening fraction greater than 29% - Ejection fraction greater than 55% with normal wall motion Other: - No uncontrolled infection - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - At least 12 weeks since prior idarubicin and recovered - At least 2 weeks since other prior chemotherapy and recovered Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CraigHurwitz, Study Chair, Maine Children's Cancer Program
Kosair Children's Hospital
Louisville, Kentucky, 40202-3830
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, 37604
United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, 55404
United States
Wesley Medical Center
Wichita, Kansas, 67214
United States
Childhood Hematology/Oncology Associates
Denver, Colorado, 80218
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Covenant Children's Hospital
Lubbock, Texas, 79410
United States
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, 11203
United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
United States
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, GIV 4G2
Canada
Newark Beth Israel Medical Center
Newark, New Jersey, 07112-2094
United States
Carilion Medical Center for Children
Roanoke, Virginia, 24013
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Miami Children's Hospital
Miami, Florida, 33155-4069
United States
Michigan State University
East Lansing, Michigan, 48824
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
Children's Hospital of Oakland
Oakland, California, 94609-1809
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Schneider Children's Hospital
New Hyde Park, New York, 11042
United States
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Australia
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Southern California Permanente Medical Group
Downey, California, 90242
United States
Nemours Children's Clinic
Jacksonville, Florida, 32207
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Laval University Medical Center
Sainte-Foy, Quebec, G1V 4G2
Canada
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
St. Mary's Hospital
West Palm Beach, Florida, 33407
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
University of South Alabama Medical Center
Mobile, Alabama, 36604
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Scott and White Memorial Hospital
Temple, Texas, 76508
United States
Academisch Ziekenhuis Groningen
Groningen, , 9700 RB
Netherlands
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
University of Miami-Jackson Memorial Hospital
Miami, Florida, 33136
United States
Jonathan Jaques Children's Cancer Center
Long Beach, California, 90801-1428
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Baystate Medical Center
Springfield, Massachusetts, 01107
United States
Dakota Cancer Institute
Fargo, North Dakota, 58103-4940
United States
Children's Medical Center - Dayton
Dayton, Ohio, 45404
United States
Rhode Island Hospital
Providence, Rhode Island, 02818
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35233
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Raymond Blank Memorial Hospital for Children
Des Moines, Iowa, 50308
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
United States
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
United States
Sydney Children's Hospital
Randwick, New South Wales, 2031
Australia
Children's Hospital of Orange County
Orange, California, 92868
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-5100
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
Medical Center of Central Georgia
Macon, Georgia, 31201
United States
Atlantic Health System
Summit, New Jersey, 07901
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Children's Hospitals and Clinics of Minnesota
St. Paul, Minnesota, 55102
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Starship Children's Hospital
Auckland, ,
New Zealand
Methodist Health Care System
San Antonio, Texas, 78229-3902
United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109-2306
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105-1080
United States
New York Medical College
Valhalla, New York, 10595
United States
Children's Hospital of Austin
Austin, Texas, 78701
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016-7710
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1081
United States
St. Louis Children's Hospital
St. Louis, Missouri, 63110
United States
Children's Hospital at Westmead
Westmead, New South Wales, 2145
Australia
Ochsner Clinic
New Orleans, Louisiana, 70121
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Cabell-Huntington Hospital, Inc
Huntington, West Virginia, 25701
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Baptist Hospital of Miami
Miami, Florida, 33176-2197
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
United States
Children's Hospital of Western Ontario
London, Ontario, N6C 2V5
Canada
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Canada
Forum Health-Tod Childrens Hospital
Youngstown, Ohio, 44501
United States
San Jorge Childrens Hospital
Santurce, , 00912
Puerto Rico
West Virginia University - Charleston
Charleston, West Virginia, 25302
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Children's Hospital Central California
Madera, California, 93638-8762
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60601
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-6769
United States
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
Royal Children's Hospital
Brisbane, Queensland, 4029
Australia
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Children's Hospital of Omaha
Omaha, Nebraska, 68114
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
United States
Presbyterian-St Luke's Medical Center
Denver, Colorado, 80218
United States
All Children's Hospital
St. Petersburg, Florida, 33701
United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260
United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, 29203
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Mott Children's Hospital
Ann Arbor, Michigan, 48109-0914
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Brooklyn Hospital Center
Brooklyn, New York, 11201
United States
Nemours Children's Clinic-Orlando
Orlando, Florida, 32806
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, 30912-4000
United States
Deaconess Medical Center
Spokane, Washington, 99210-0248
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, 92120
United States
Marshfield Clinic
Marshfield, Wisconsin, 54449-5772
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
Sioux Valley Hospital
Sioux Falls, South Dakota, 57117
United States
Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Group Health Cooperative
Seattle, Washington, 98112
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201-1595
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Children's Hospital
Hamilton, Ontario, L8N 3Z5
Canada
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Floating Hospital for Children
Boston, Massachusetts, 02111
United States
Children's Hospital San Diego
San Diego, California, 92123-4282
United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, 33021
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Sacred Heart Children's Hospital
Pensacola, Florida, 32504
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074
United States
Swiss Pediatric Oncology Group Geneva
Geneva, , CH 1211
Switzerland
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021-4885
United States
Tampa Children's Hospital
Tampa, Florida, 33677-4227
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-9070
United States
John Stoddard Cancer Center
Des Moines, Iowa, 50309
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Canada
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Swiss Pediatric Oncology Group Lausanne
Lausanne, , CH 1011
Switzerland
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2168
United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, 79106
United States
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, 55805-1983
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
St. John Hospital and Medical Center
Detroit, Michigan, 48236
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9658
United States
Children's Hospital of Denver
Denver, Colorado, 80218-1088
United States
East Tennessee Children's Hospital
Knoxville, Tennessee, 37901
United States
Lutheran General Hospital
Park Ridge, Illinois, 60068-1174
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131
United States
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Sutter Cancer Center
Sacramento, California, 95816
United States
Mary Bridge Children's Health Center
Tacoma, Washington, 98415-0299
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Hope Children's Hospital
Oak Lawn, Illinois, 60453
United States
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Swiss Pediatric Oncology Group Bern
BERN, , CH 3010
Switzerland
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Alfred I. Dupont Institute
Wilmington, Delaware, 19899
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32803
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-1320
United States
Toledo Children's Hospital
Toledo, Ohio, 43601
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
Children's Hospital of Southwest Florida
Ft. Myers, Florida, 33908
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0284
United States
Memorial Health University Medical Center, Inc.
Savannah, Georgia, 31403-3089
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0361
United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, 94115
United States
Additional Information:
Study ID Numbers: CDR0000065993; COG-P9720,POG-9720
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003178
Other Acute Myeloid Leukemia Studies:
1. Acute Myeloid Leukemia Study
2. Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML)
3. Phase 2 Study of ZARNESTRA™ as Postconsolidation Therapy for Acute Myeloid Leukemia in Subjects 60 Years & Older
4. Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia
5. Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Related Studies:
Other Acute Myeloid Leukemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
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