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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia



Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

For Condition: recurrent childhood acute lymphoblastic leukemia,recurrent childhood acute myeloid leukemia
Status: Suspended
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.
Details: OBJECTIVES: - Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine. - Assess the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia). Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia - M3 marrow (at least 25% blasts in bone marrow aspirate) - Refractory to conventional therapy PATIENT CHARACTERISTICS: Age: - 21 and under at diagnosis Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - At least 2 months Hematopoietic: - Not specified Hepatic: - Bilirubin normal - SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunomodulating agents Chemotherapy: - At least 2 weeks since prior chemotherapy - No other concurrent chemotherapy for cancer Endocrine therapy: - No concurrent corticosteroids except for treatment of adrenal crises with suppressed pituitary/adrenal response - Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic reactions to amphotericin or transfusions Radiotherapy: - Concurrent radiotherapy to localized painful lesions allowed Surgery: - Not specified Other: - Recovered from any prior therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AnneAngiolillo,  Study Chair,  Children's National Medical Center

Sioux Valley Hospital
Sioux Falls,  South Dakota,  57117
United States
 

Starship Children's Hospital
Auckland,  , 
New Zealand
 

Group Health Cooperative
Seattle,  Washington,  98112
United States
 

Saint Jude Midwest Affiliate
Peoria,  Illinois,  61637
United States
 

Dana-Farber Cancer Institute
Boston,  Massachusetts,  02115
United States
 

Kosair Children's Hospital
Louisville,  Kentucky,  40202-3830
United States
 

East Tennessee State University Cancer Center at JCMC
Johnson City,  Tennessee,  37604
United States
 

Lombardi Cancer Center
Washington D.C.,  District of Columbia,  20007
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60601
United States
 

Albert Einstein Clinical Cancer Center
Bronx,  New York,  10461
United States
 

Phoenix Children's Hospital
Phoenix,  Arizona,  85016-7710
United States
 

Ochsner Clinic
New Orleans,  Louisiana,  70121
United States
 

Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore,  Maryland,  21201-1595
United States
 

Memorial Health University Medical Center, Inc.
Savannah,  Georgia,  31403-3089
United States
 

Avera Cancer Institute
Sioux Falls,  South Dakota,  57105-1080
United States
 

Children's Hospital of Oklahoma
Oklahoma City,  Oklahoma,  73104
United States
 

Brookdale University Hospital and Medical Center
Brooklyn,  New York,  11212
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78207
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

Maine Children's Cancer Program
Scarborough,  Maine,  04074
United States
 

Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08903
United States
 

Cabell-Huntington Hospital, Inc
Huntington,  West Virginia,  25701
United States
 

Medical Center of Central Georgia
Macon,  Georgia,  31201
United States
 

Children's Hospital of Michigan
Detroit,  Michigan,  48201
United States
 

Raymond Blank Memorial Hospital for Children
Des Moines,  Iowa,  50308
United States
 

San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base,  Texas,  78236-5300
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

Medical College of Georgia Comprehensive Cancer Center
Augusta,  Georgia,  30912-4000
United States
 

Children's Hospital of Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Princess Margaret Hospital for Children
Perth,  Western Australia,  6001
Australia
 

Children's Hospital of Eastern Ontario
Ottawa,  Ontario,  K1H 8L1
Canada
 

St. Vincent Hospital and Health Care Center
Indianapolis,  Indiana,  46260
United States
 

Scott and White Memorial Hospital
Temple,  Texas,  76508
United States
 

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

Sunrise Hospital and Medical Center
Las Vegas,  Nevada,  89109-2306
United States
 

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 

David Grant Medical Center
Travis Air Force Base,  California,  94535
United States
 

West Virginia University - Charleston
Charleston,  West Virginia,  25302
United States
 

Marshfield Clinic
Marshfield,  Wisconsin,  54449-5772
United States
 

Joe DiMaggio Children's Hospital at Memorial
Hollywood,  Florida,  33021
United States
 

St. Louis Children's Hospital
St. Louis,  Missouri,  63110
United States
 

Children's Hospital San Diego
San Diego,  California,  92123-4282
United States
 

Gundersen Lutheran Medical Center
La Crosse,  Wisconsin,  54601
United States
 

Children's Hospitals and Clinics - Minneapolis
Minneapolis,  Minnesota,  55404
United States
 

Children's Hospital of the King's Daughters
Norfolk,  Virginia,  23507
United States
 

Florida Hospital Cancer Institute
Orlando,  Florida,  32803
United States
 

Floating Hospital for Children
Boston,  Massachusetts,  02111
United States
 

West Virginia University Hospitals
Morgantown,  West Virginia,  26506-9300
United States
 

Tulane University School of Medicine
New Orleans,  Louisiana,  70112
United States
 

Children's Hospital of Oakland
Oakland,  California,  94609-1809
United States
 

Alfred I. Dupont Institute
Wilmington,  Delaware,  19899
United States
 

Rush-Presbyterian-St. Luke's Medical Center
Chicago,  Illinois,  60612
United States
 

Methodist Health Care System
San Antonio,  Texas,  78229-3902
United States
 

University of California Davis Medical Center
Sacramento,  California,  95817
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

Bellin Memorial Hospital
Green Bay,  Wisconsin,  54301
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

Royal Children's Hospital
Brisbane,  Queensland,  4029
Australia
 

Children's Hospital of Columbus
Columbus,  Ohio,  43205-2696
United States
 

St. Barnabas Medical Center
Livingston,  New Jersey,  07039
United States
 

Milton S. Hershey Medical Center
Hershey,  Pennsylvania,  17033-0850
United States
 

Laval University Medical Center
Sainte-Foy,  Quebec,  G1V 4G2
Canada
 

Mount Sinai School of Medicine
New York City,  New York,  10029
United States
 

Legacy Emanuel Hospital and Health Center
Portland,  Oregon,  97227
United States
 

Baptist Hospital of Miami
Miami,  Florida,  33176-2197
United States
 

Shands Hospital and Clinics, University of Florida
Gainesville,  Florida,  32610-100277
United States
 

Toledo Children's Hospital
Toledo,  Ohio,  43601
United States
 

Children's Medical Center - Dayton
Dayton,  Ohio,  45404
United States
 

Sutter Cancer Center
Sacramento,  California,  95816
United States
 

State University of New York - Upstate Medical University
Syracuse,  New York,  13210
United States
 

Cardinal Glennon Children's Hospital
St. Louis,  Missouri,  63104
United States
 

Swiss Pediatric Oncology Group Geneva
Geneva,  ,  CH 1211
Switzerland
 

Doernbecher Children's Hospital
Portland,  Oregon,  97201-3098
United States
 

Kaiser Permanente Medical Center - Santa Clara
Santa Clara,  California,  95051-5386
United States
 

Southern California Permanente Medical Group
Downey,  California,  90242
United States
 

Miami Children's Hospital
Miami,  Florida,  33155-4069
United States
 

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,  Maryland,  21231-2410
United States
 

Cedars-Sinai Medical Center
Los Angeles,  California,  90048
United States
 

St. Mary's Hospital
West Palm Beach,  Florida,  33407
United States
 

Royal Children's Hospital
Parkville,  Victoria,  3052
Australia
 

Hopital Sainte Justine
Montreal,  Quebec,  H3T 1C5
Canada
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5289
United States
 

Children's Hospital of New Orleans
New Orleans,  Louisiana,  70118
United States
 

Baylor College of Medicine
Houston,  Texas,  77030
United States
 

Broward General Medical Center
Ft. Lauderdale,  Florida,  33316
United States
 

Texas Tech University Health Sciences Center School of Medicine
Amarillo,  Texas,  79106
United States
 

Children's Hospital
Hamilton,  Ontario,  L8N 3Z5
Canada
 

Mott Children's Hospital
Ann Arbor,  Michigan,  48109-0914
United States
 

East Carolina University School of Medicine
Greenville,  North Carolina,  27858-4354
United States
 

Natalie Warren Bryant Cancer Center
Tulsa,  Oklahoma,  74136
United States
 

University of Illinois at Chicago
Chicago,  Illinois,  60612
United States
 

State University of New York Health Sciences Center - Stony Brook
Stony Brook,  New York,  11790-7775
United States
 

Tripler Army Medical Center
Honolulu,  Hawaii,  96859-5000
United States
 

CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay,  Wisconsin,  54301
United States
 

Santa Barbara Cottage Hospital
Santa Barbara,  California,  93102
United States
 

Cancer Research Center of Hawaii
Honolulu,  Hawaii,  96813
United States
 

Loma Linda University Medical Center
Loma Linda,  California,  92354
United States
 

Forum Health-Tod Childrens Hospital
Youngstown,  Ohio,  44501
United States
 

Children's Hospital at Westmead
Westmead,  New South Wales,  2145
Australia
 

Women's and Children's Hospital
North Adelaide,  South Australia,  5006
Australia
 

Rebecca and John Moores UCSD Cancer Center
La Jolla,  California,  92093-0658
United States
 

Spectrum Health and DeVos Children's Hospital
Grand Rapids,  Michigan,  49503
United States
 

William Beaumont Hospital
Royal Oak,  Michigan,  48073-6769
United States
 

Lutheran General Hospital
Park Ridge,  Illinois,  60068-1174
United States
 

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

University of Wisconsin Hospital and Clinics
Madison,  Wisconsin,  53792-0001
United States
 

University of South Alabama Medical Center
Mobile,  Alabama,  36604
United States
 

Children's Hospitals and Clinics of Minnesota
St. Paul,  Minnesota,  55102
United States
 

Children's Hospital Los Angeles
Los Angeles,  California,  90027-0700
United States
 

Children's Hospital of Western Ontario
London,  Ontario,  N6C 2V5
Canada
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0284
United States
 

Children's National Medical Center
Washington D.C.,  District of Columbia,  20010-2970
United States
 

Children's Hospital of Omaha
Omaha,  Nebraska,  68114
United States
 

Medical City Dallas Hospital
Dallas,  Texas,  75230
United States
 

Vermont Cancer Center
Burlington,  Vermont,  05401-3498
United States
 

Norris Cotton Cancer Center
Lebanon,  New Hampshire,  03756-0002
United States
 

University of New Mexico Cancer Research and Treatment Center
Albuquerque,  New Mexico,  87131
United States
 

Alberta Children's Hospital
Calgary,  Alberta,  T2T 5C7
Canada
 

Nemours Children's Clinic
Jacksonville,  Florida,  32207
United States
 

Mountain States Tumor Institute
Boise,  Idaho,  83712
United States
 

Naval Medical Center, Portsmouth
Portsmouth,  Virginia,  23708-5100
United States
 

Children's Hospital of Pittsburgh
Pittsburgh,  Pennsylvania,  15213
United States
 

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham,  Alabama,  35233
United States
 

Bronson Methodist Hospital
Kalamazoo,  Michigan,  49007
United States
 

University of Connecticut Health Center
Farmington,  Connecticut,  06360-7106
United States
 

Midwest Children's Cancer Center
Milwaukee,  Wisconsin,  53226
United States
 

Sinai Hospital of Baltimore
Baltimore,  Maryland,  21225
United States
 

Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco,  California,  94115
United States
 

St. Mary's/Duluth Clinic Cancer Center
Duluth,  Minnesota,  55805-1983
United States
 

Swiss Pediatric Oncology Group Lausanne
Lausanne,  ,  CH 1011
Switzerland
 

Tampa Children's Hospital
Tampa,  Florida,  33677-4227
United States
 

Hurley Medical Center
Flint,  Michigan,  48503
United States
 

Cancer Center at the University of Virginia
Charlottesville,  Virginia,  22908
United States
 

New York Medical College
Valhalla,  New York,  10595
United States
 

East Tennessee Children's Hospital
Knoxville,  Tennessee,  37901
United States
 

Newark Beth Israel Medical Center
Newark,  New Jersey,  07112-2094
United States
 

Children's Hospital Medical Center - Cincinnati
Cincinnati,  Ohio,  45229-3039
United States
 

Geisinger Medical Center
Danville,  Pennsylvania,  17822-1320
United States
 

British Columbia Children's Hospital
Vancouver,  British Columbia,  V6H 3V4
Canada
 

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

Children's Hospital of Southwest Florida
Ft. Myers,  Florida,  33908
United States
 

St. Joseph's Hospital and Medical Center
Paterson,  New Jersey,  07503
United States
 

Children's Hospital of Denver
Denver,  Colorado,  80218-1088
United States
 

Hope Children's Hospital
Oak Lawn,  Illinois,  60453
United States
 

Children's Hospital of Greenville Hospital System
Greenville,  South Carolina,  29605
United States
 

Inova Fairfax Hospital
Falls Church,  Virginia,  22042-3300
United States
 

Children's Mercy Hospital
Kansas City,  Missouri,  64108
United States
 

University of Nebraska Medical Center
Omaha,  Nebraska,  68198-2168
United States
 

San Jorge Childrens Hospital
Santurce,  ,  00912
Puerto Rico
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

UCSF Comprehensive Cancer Center
San Francisco,  California,  94143-0128
United States
 

Wesley Medical Center
Wichita,  Kansas,  67214
United States
 

IWK Health Centre
Halifax,  Nova Scotia,  B3J 3G9
Canada
 

Children's Hospital and Regional Medical Center - Seattle
Seattle,  Washington,  98105
United States
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Dakota Cancer Institute
Fargo,  North Dakota,  58103-4940
United States
 

St. Vincent Hospital
Green Bay,  Wisconsin,  54307-9070
United States
 

Presbyterian Healthcare
Charlotte,  North Carolina,  28233-3549
United States
 

University of Miami-Jackson Memorial Hospital
Miami,  Florida,  33136
United States
 

Children's Memorial Hospital - Chicago
Chicago,  Illinois,  60614
United States
 

University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan,  ,  00936-5067
Puerto Rico
 

Madigan Army Medical Center
Tacoma,  Washington,  98431-5000
United States
 

Children's Hospital of Orange County
Orange,  California,  92868
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

Presbyterian-St Luke's Medical Center
Denver,  Colorado,  80218
United States
 

Sacred Heart Children's Hospital
Pensacola,  Florida,  32504
United States
 

CancerCare Manitoba
Winnipeg,  Manitoba,  R3E 0V9
Canada
 

Janeway Children's Health and Rehabilitation Centre
St. John's,  Newfoundland and Labrador,  A1B 3V6
Canada
 

Southern Illinois University School of Medicine
Springfield,  Illinois,  62794-9658
United States
 

Palmetto Health South Carolina Cancer Center
Columbia,  South Carolina,  29203
United States
 

New York Presbyterian Hospital - Cornell Campus
New York City,  New York,  10021-4885
United States
 

Covenant Children's Hospital
Lubbock,  Texas,  79410
United States
 

Nemours Children's Clinic-Orlando
Orlando,  Florida,  32806
United States
 

Hospital for Sick Children
Toronto,  Ontario,  M5G 1X8
Canada
 

Children's Hospital Medical Center of Akron
Akron,  Ohio,  44308
United States
 

Carolinas Medical Center
Charlotte,  North Carolina,  28232-2861
United States
 

Cross Cancer Institute
Edmonton,  Alberta,  T6G 1Z2
Canada
 

St. John Hospital and Medical Center
Detroit,  Michigan,  48236
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

Saint Jude Children's Research Hospital
Memphis,  Tennessee,  38105-2794
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 

McGill University Health Center - Montreal Children's Hospital
Montreal,  Quebec,  H3H 1P3
Canada
 

Mission Saint Joseph's Health System
Asheville,  North Carolina,  28801
United States
 

Holden Comprehensive Cancer Center
Iowa City,  Iowa,  52242-1009
United States
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0361
United States
 

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego,  California,  92120
United States
 

Medical College of Ohio Hospital
Madison,  Wisconsin,  53792-6164
United States
 

Vanderbilt-Ingram Cancer Center
Nashville,  Tennessee,  37232-6838
United States
 

Cook Children's Medical Center - Fort Worth
Ft. Worth,  Texas,  76104
United States
 

Children's Healthcare of Atlanta - Scottish Rite
Atlanta,  Georgia,  30342
United States
 

State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn,  New York,  11203
United States
 

Maimonides Medical Center
Brooklyn,  New York,  11219
United States
 

Jonathan Jaques Children's Cancer Center
Long Beach,  California,  90801-1428
United States
 

Eastern Maine Medical Center
Bangor,  Maine,  04401
United States
 

Hackensack University Medical Center
Hackensack,  New Jersey,  07601
United States
 

Schneider Children's Hospital
New Hyde Park,  New York,  11042
United States
 

Fred Hutchinson Cancer Research Center
Seattle,  Washington,  98109-1024
United States
 

Academisch Ziekenhuis Groningen
Groningen,  ,  9700 RB
Netherlands
 

Children's Hospital Central California
Madera,  California,  93638-8762
United States
 

Baystate Medical Center
Springfield,  Massachusetts,  01107
United States
 

Cancer Center of Albany Medical Center
Albany,  New York,  12208
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
 

James P. Wilmot Cancer Center
Rochester,  New York,  14642
United States
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4009
United States
 

Deaconess Medical Center
Spokane,  Washington,  99210-0248
United States
 

Carilion Medical Center for Children
Roanoke,  Virginia,  24013
United States
 

Saskatoon Cancer Centre
Saskatoon,  Saskatchewan,  S7N 4H4
Canada
 

University of Massachusetts Memorial Medical Center - University Campus
Worcester,  Massachusetts,  01655
United States
 

Yale Comprehensive Cancer Center
New Haven,  Connecticut,  06520-8028
United States
 

Swiss Pediatric Oncology Group Bern
BERN,  ,  CH 3010
Switzerland
 

Atlantic Health System
Summit,  New Jersey,  07901
United States
 

Allan Blair Cancer Centre
Regina,  Saskatchewan,  S4T 7T1
Canada
 

All Children's Hospital
St. Petersburg,  Florida,  33701
United States
 

Michigan State University
East Lansing,  Michigan,  48824
United States
 

St. Christopher's Hospital for Children
Philadelphia,  Pennsylvania,  19134-1095
United States
 

Sydney Children's Hospital
Randwick,  New South Wales,  2031
Australia
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010-3000
United States
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Brooklyn Hospital Center
Brooklyn,  New York,  11201
United States
 

Columbia Presbyterian Hospital
New York City,  New York,  10032
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068271;  COG-ADVL0022,CCG-A0999
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006462

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