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Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia Clinical research trials and Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia. Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia clinical trial. Participants oftentimes recieve the finest healthcare available for their Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia  Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
For Condition: childhood acute myeloblastic leukemia with maturation (M2),childhood acute myeloblastic leukemia without maturation (M1),childhood acute myeloid leukemia in remission,recurrent childhood acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology Group
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-2 after autologous bone marrow transplantation in pediatric patients with acute myeloid leukemia. II. Determine toxic effects of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-7, 9-14, and 16-22. On days 8 and 15, patients receive IL-2 IV over 2 hours. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6-9 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose-limiting toxicity. Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 6-27 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KimoStine, Study Chair, Pediatric Oncology Group
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
United States
Carilion Roanoke Community Hospital
Roanoke, Virginia, 24029
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
St. Mary's Hospital
West Palm Beach, Florida, 33407
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Baptist Hospital of Miami
Miami, Florida, 33176-2197
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of South Alabama Medical Center
Mobile, Alabama, 36617-2293
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Scott and White Clinic
Temple, Texas, 76508
United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Schneider Children's Hospital
New Hyde Park, New York, 11042
United States
Children's Hospital
Hamilton, Ontario, L8N 3Z5
Canada
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
United States
University of Miami-Jackson Memorial Hospital Medical Center
Miami, Florida, 33136
United States
Clinique de Pediatrie
Geneva, , 1211
Switzerland
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
United States
Laval University Medical Center
Sainte-Foy, Quebec, G1V 4G2
Canada
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
All Children's Hospital
St. Petersburg, Florida, 33701
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
West Virginia University Medical School-Charleston
Charleston, West Virginia, 25304
United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, 78229-3900
United States
Maine Children's Cancer Program
Portland, Maine, 04101
United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, 73126-0307
United States
Nemours Children's Clinic
Jacksonville, Florida, 32207
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Florida Pediatric
Tampa, Florida, 33682-7757
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
San Jorge Childrens Hospital
Santurce, , 00912
Puerto Rico
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
James H. Quillen College of Medicine
Johnson City, Tennessee, 37614-0622
United States
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Canada
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Canada
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Hope Children's Hospital
Oak Lawn, Illinois, 60453
United States
Children's Hospital of Southwest Florida
Ft. Myers, Florida, 33908
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214
United States
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Children's Hospital and Health Center
San Diego, California, 92123-4282
United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Miami Children's Hospital
Miami, Florida, 33155
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32803
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
United States
Texas Oncology P.A.
Dallas, Texas, 75230-2503
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
St. John's Hospital and Medical Center
Detroit, Michigan, 48236
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78466
United States
Swiss Pediatric Oncology Group Bern
BERN, , CH 3010
Switzerland
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, GIV 4G2
Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Additional Information:
Study ID Numbers: CDR0000065574; POG-9674
Study Start Date: March 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009698
Other Childhood Acute Myeloblastic Leukemia Without Maturation (m1) Studies:
1. Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
2. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
3. Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Low-Dose Interleukin-2 in Treating Patients With Acute Myelogenous Leukemia
Related Studies:
Other childhood acute myeloblastic leukemia without maturation (M1) Clinical Trials
Other North Carolina Clinical Trials
Other Charlotte Clinical Trials
Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
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