Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
Leukemia

About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute myeloid leukemia, childhood acute myeloid leukemia in remission, childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2)
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) Must have received autologous bone marrow or stem cell transplantation for AML within the past 28 to 100 days Evidence of marrow engraftment Absolute neutrophil count at least 500/mm3 for at least 2 consecutive days Platelet count at least 20,000/mm3 without transfusion support for more than 3 days Documented M1 or M2 bone marrow within the past 7 days PATIENT CHARACTERISTICS: Age: Under 22 at diagnosis Performance status: Karnofsky 50-100% Life expectancy: At least 8 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times normal Renal: Creatinine normal OR Glomerular filtration rate at least 70 mL/min Cardiovascular: Shortening fraction at least 27% OR Ejection fraction greater than 50% No evidence of active cardiac disease by electrocardiogram Pulmonary: No evidence of active pulmonary disease by chest x-ray Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Neurologic deficits due to CNS disease must be stable within the past 4 weeks No active viral, bacterial, or invasive fungal infection No fever No prior hypersensitivity to interleukin-2 No greater than grade 2 mucosal toxicity PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 3 days since prior growth factors or intravenous immunoglobulin No concurrent cytokines or growth factors No concurrent intravenous immunoglobulin Chemotherapy: No concurrent chemotherapy No concurrent methotrexate IV or intrathecally Endocrine therapy: At least 3 days since prior corticosteroids No concurrent corticosteroids (except as premedication for documented severe transfusion reactions) Radiotherapy: Not specified Surgery: Not specified Other: At least 3 days since prior pentoxifylline or amphotericin B No concurrent pentoxifylline No other concurrent anticancer therapy
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- University of South Alabama Medical Center
- MBCCOP - Gulf Coast
- Arizona Cancer Center
- Arkansas Children's Hospital
- University of Arkansas for Medical Sciences
- University of California San Diego Cancer Center
- Lucile Packard Children's Hospital at Stanford
- Sutter Cancer Center
- University of California Davis Medical Center
- Kaiser Permanente-Southern California Permanente Medical Group
- Children's Hospital and Health Center
- Kaiser Permanente Medical Center - Santa Clara
- Yale Comprehensive Cancer Center
- Walter Reed Army Medical Center
- Broward General Medical Center
- Children's Hospital of Southwest Florida
- Shands Hospital and Clinics, University of Florida
- Nemours Children's Clinic
- Sylvester Cancer Center, University of Miami
- University of Miami-Jackson Memorial Hospital Medical Center
- Miami Children's Hospital
- Baptist Hospital of Miami
- Walt Disney Memorial Cancer Institute
- All Children's Hospital
- CCOP - Florida Pediatric
- St. Mary's Hospital
- Emory University Hospital - Atlanta
- Cancer Research Center of Hawaii
- Tripler Army Medical Center
- Rush-Presbyterian-St. Luke's Medical Center
- Children's Memorial Hospital, Chicago
- Hope Children's Hospital
- CCOP - Illinois Oncology Research Association
- Saint Jude Midwest Affiliate
- University of Kansas Medical Center
- CCOP - Wichita
- Via Christi Regional Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- CCOP - Ochsner
- Eastern Maine Medical Center
- Maine Children's Cancer Program
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Boston Floating Hospital Infants and Children
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center
- Children's Hospital of Michigan
- St. John's Hospital and Medical Center
- Hurley Medical Center
- University of Mississippi Medical Center
- Keesler Medical Center - Keesler AFB
- University of Missouri-Columbia Hospital and Clinics
- Cardinal Glennon Children's Hospital
- Washington University School of Medicine
- Norris Cotton Cancer Center
- CCOP - Northern New Jersey
- Hackensack University Medical Center
- University of New Mexico School of Medicine
- Roswell Park Cancer Institute
- Schneider Children's Hospital
- Mount Sinai School of Medicine
- University of Rochester Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- State University of New York - Upstate Medical University
- Mission Saint Joseph's Health System
- Carolinas Medical Center
- Presbyterian Healthcare
- Duke Comprehensive Cancer Center
- East Carolina University School of Medicine
- Comprehensive Cancer Center at Wake Forest University
- Oklahoma Memorial Hospital
- Natalie Warren Bryant Cancer Center
- CCOP - Columbia River Program
- Legacy Emanuel Hospital and Health Center
- St. Christopher's Hospital for Children
- Medical University of South Carolina
- Children's Hospital of Greenville Hospital System
- James H. Quillen College of Medicine
- Saint Jude Children's Research Hospital
- Driscoll Children's Hospital
- Texas Oncology P.A.
- Medical City Dallas Hospital
- Simmons Cancer Center - Dallas
- Cook Children's Medical Center - Fort Worth
- University of Texas Medical Branch
- Baylor College of Medicine
- San Antonio Military Pediatric Cancer and Blood Disorders Center
- MBCCOP - South Texas Pediatric
- University of Texas Health Science Center at San Antonio
- Scott and White Clinic
- Vermont Cancer Center
- Cancer Center at the University of Virginia
- Inova Fairfax Hospital
- Naval Medical Center, Portsmouth
- Massey Cancer Center
- Carilion Roanoke Community Hospital
- Madigan Army Medical Center
- West Virginia University Medical School-Charleston
- West Virginia University Hospitals
- St. Vincent Hospital
- Midwest Children's Cancer Center
- Royal Children's Hospital
- Alberta Children's Hospital
- Cross Cancer Institute
- Children's Hospital
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- McGill University Health Center - Montreal Children's Hospital
- Hopital Sainte Justine
- Centre Hospitalier de L'Universite Laval
- Laval University Medical Center
- Academisch Ziekenhuis Groningen
- San Jorge Childrens Hospital
- Swiss Pediatric Oncology Group Bern
- Clinique de Pediatrie
- Centre Hospitalier Universitaire Vaudois
Arms of the Study
Arm 1
Experimental
All patients
Day 1 through day 7, days 9-14 and days 16-22: The assigned dose of IL-2 will be administered SQ. On days 8 and 15, IL-2 will be administered as a 2 hour intravenous infusion of one million units/M2 of IL-2. After day 22 there will be a 7 day rest period before beginning the next cycle. The next cycle will repeat just as above. This will be repeated for a maximum of 4 total cycles of 21 days of IL-2 therapy. The maintenance dose of IL-2 will always be the same as given during cycle one, unless there is dose limiting toxicity.