Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- University of South Alabama Medical Center
- Phoenix Children's Hospital
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center
- Children's Hospital Los Angeles
- Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center, UCLA
- Children's Hospital Central California
- Children's Hospital of Oakland
- Chao Family Comprehensive Cancer Center
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital at Stanford
- Sutter Cancer Center
- University of California Davis Medical Center
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
- Children's Hospital San Diego
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- UCSF Comprehensive Cancer Center
- Santa Barbara Cottage Hospital
- Kaiser Permanente Medical Center - Santa Clara
- David Grant Medical Center
- Children's Hospital of Denver
- Presbyterian-St Luke's Medical Center
- University of Connecticut Health Center
- Yale Comprehensive Cancer Center
- Alfred I. Dupont Institute
- Lombardi Cancer Center
- Children's National Medical Center
- Walter Reed Army Medical Center
- Broward General Medical Center
- Children's Hospital of Southwest Florida
- Shands Hospital and Clinics, University of Florida
- Joe DiMaggio Children's Hospital at Memorial
- Nemours Children's Clinic
- University of Miami-Jackson Memorial Hospital
- Miami Children's Hospital
- Baptist Hospital of Miami
- Florida Hospital Cancer Institute
- Nemours Children's Clinic-Orlando
- Sacred Heart Children's Hospital
- All Children's Hospital
- Tampa Children's Hospital
- St. Mary's Hospital
- Emory University Hospital - Atlanta
- Children's Healthcare of Atlanta - Scottish Rite
- Medical College of Georgia Comprehensive Cancer Center
- Medical Center of Central Georgia
- Memorial Health University Medical Center, Inc.
- Cancer Research Center of Hawaii
- Tripler Army Medical Center
- Mountain States Tumor Institute
- University of Chicago Cancer Research Center
- Rush-Presbyterian-St. Luke's Medical Center
- University of Illinois at Chicago
- Children's Memorial Hospital - Chicago
- Hope Children's Hospital
- Lutheran General Hospital
- Saint Jude Midwest Affiliate
- Southern Illinois University School of Medicine
- Indiana University Cancer Center
- St. Vincent Hospital and Health Care Center
- Raymond Blank Memorial Hospital for Children
- Holden Comprehensive Cancer Center
- Wesley Medical Center
- Albert B. Chandler Medical Center, University of Kentucky
- Kosair Children's Hospital
- Tulane University School of Medicine
- Children's Hospital of New Orleans
- Ochsner Clinic
- Eastern Maine Medical Center
- Maine Children's Cancer Program
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Sinai Hospital of Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children
- Dana-Farber Cancer Institute
- Baystate Medical Center
- University of Massachusetts Memorial Medical Center - University Campus
- Mott Children's Hospital
- Children's Hospital of Michigan
- Henry Ford Hospital
- St. John Hospital and Medical Center
- Michigan State University
- Hurley Medical Center
- Spectrum Health and DeVos Children's Hospital
- Bronson Methodist Hospital
- William Beaumont Hospital
- St. Mary's/Duluth Clinic Cancer Center
- Children's Hospitals and Clinics - Minneapolis
- Mayo Clinic Cancer Center
- Children's Hospitals and Clinics of Minnesota
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- St. Louis Children's Hospital
- Children's Hospital of Omaha
- University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center
- Hackensack University Medical Center
- St. Barnabas Medical Center
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- Atlantic Health System
- University of New Mexico Cancer Research and Treatment Center
- Cancer Center of Albany Medical Center
- Albert Einstein Clinical Cancer Center
- Brooklyn Hospital Center
- State University of New York Health Science Center at Brooklyn College of Medicine
- Brookdale University Hospital and Medical Center
- Maimonides Medical Center
- Roswell Park Cancer Institute
- North Shore University Hospital
- Schneider Children's Hospital
- New York Presbyterian Hospital - Cornell Campus
- Memorial Sloan-Kettering Cancer Center
- Mount Sinai School of Medicine
- Columbia Presbyterian Hospital
- James P. Wilmot Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- State University of New York - Upstate Medical University
- New York Medical College
- Mission Saint Joseph's Health System
- Lineberger Comprehensive Cancer Center, UNC
- Carolinas Medical Center
- Presbyterian Healthcare
- Duke Comprehensive Cancer Center
- East Carolina University School of Medicine
- Dakota Cancer Institute
- Children's Hospital Medical Center of Akron
- Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic Taussig Cancer Center
- Children's Hospital of Columbus
- Children's Medical Center - Dayton
- Toledo Children's Hospital
- Forum Health-Tod Childrens Hospital
- Children's Hospital of Oklahoma
- Natalie Warren Bryant Cancer Center
- Doernbecher Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Geisinger Medical Center
- Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh
- Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Children's Hospital of Greenville Hospital System
- Avera Cancer Institute
- Sioux Valley Hospital
- East Tennessee State University Cancer Center at JCMC
- East Tennessee Children's Hospital
- Saint Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine
- Medical City Dallas Hospital
- Simmons Cancer Center - Dallas
- Cook Children's Medical Center - Fort Worth
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Baylor College of Medicine
- San Antonio Military Pediatric Cancer and Blood Disorders Center
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Health Care System
- Scott and White Memorial Hospital
- Huntsman Cancer Institute
- Vermont Cancer Center
- Cancer Center at the University of Virginia
- Inova Fairfax Hospital
- Children's Hospital of the King's Daughters
- Naval Medical Center, Portsmouth
- Massey Cancer Center
- Carilion Medical Center for Children
- Children's Hospital and Regional Medical Center - Seattle
- Fred Hutchinson Cancer Research Center
- Group Health Cooperative
- Deaconess Medical Center
- Madigan Army Medical Center
- West Virginia University - Charleston
- Cabell-Huntington Hospital, Inc
- West Virginia University Hospitals
- Bellin Memorial Hospital
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- St. Vincent Hospital
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Medical College of Ohio Hospital
- Marshfield Clinic
- Midwest Children's Cancer Center
- Sydney Children's Hospital
- Children's Hospital at Westmead
- Royal Children's Hospital
- Women's and Children's Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- Cross Cancer Institute
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- Children's Hospital
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- McGill University Health Center - Montreal Children's Hospital
- Hopital Sainte Justine
- Laval University Medical Center
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Academisch Ziekenhuis Groningen
- Starship Children's Hospital
- University of Puerto Rico School of Medicine Medical Sciences Campus
- San Jorge Childrens Hospital
- Swiss Pediatric Oncology Group Bern
- Swiss Pediatric Oncology Group Geneva
- Swiss Pediatric Oncology Group Lausanne
Arms of the Study
Arm 1
Experimental
Relapsed acute lymphoblastic and acute Myelogenous leukemia
Gemcitabine hydrochloride will be given as 10 mg/m2/min x 360 minutes weekly for three weeks. After a one-week rest period it may be repeated in patients without progressive disease or limiting toxicity.