Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

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Full Description

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.

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.

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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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00009698

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 114 Locations for this study

See Locations Near You

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
University of South Alabama Medical Center
Mobile Alabama, 36617, United States
MBCCOP - Gulf Coast
Mobile Alabama, 36688, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
University of California San Diego Cancer Center
La Jolla California, 92093, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto California, 94304, United States
Sutter Cancer Center
Sacramento California, 95816, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
Children's Hospital and Health Center
San Diego California, 92123, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara California, 95051, United States
Yale Comprehensive Cancer Center
New Haven Connecticut, 06520, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Broward General Medical Center
Fort Lauderdale Florida, 33316, United States
Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States
Shands Hospital and Clinics, University of Florida
Gainesville Florida, 32610, United States
Nemours Children's Clinic
Jacksonville Florida, 32207, United States
Sylvester Cancer Center, University of Miami
Miami Florida, 33136, United States
University of Miami-Jackson Memorial Hospital Medical Center
Miami Florida, 33136, United States
Miami Children's Hospital
Miami Florida, 33155, United States
Baptist Hospital of Miami
Miami Florida, 33176, United States
Walt Disney Memorial Cancer Institute
Orlando Florida, 32803, United States
All Children's Hospital
St. Petersburg Florida, 33701, United States
CCOP - Florida Pediatric
Tampa Florida, 33682, United States
St. Mary's Hospital
West Palm Beach Florida, 33407, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
Children's Memorial Hospital, Chicago
Chicago Illinois, 60614, United States
Hope Children's Hospital
Oak Lawn Illinois, 60453, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Maine Children's Cancer Program
Portland Maine, 04101, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Boston Floating Hospital Infants and Children
Boston Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
Children's Hospital of Michigan
Detroit Michigan, 48201, United States
St. John's Hospital and Medical Center
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48503, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler AFB Mississippi, 39534, United States
University of Missouri-Columbia Hospital and Clinics
Columbia Missouri, 65212, United States
Cardinal Glennon Children's Hospital
Saint Louis Missouri, 63104, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
University of New Mexico School of Medicine
Albuquerque New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Schneider Children's Hospital
New Hyde Park New York, 11042, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11790, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Mission Saint Joseph's Health System
Asheville North Carolina, 28801, United States
Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Presbyterian Healthcare
Charlotte North Carolina, 28233, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
East Carolina University School of Medicine
Greenville North Carolina, 27858, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Oklahoma Memorial Hospital
Oklahoma City Oklahoma, 73126, United States
Natalie Warren Bryant Cancer Center
Tulsa Oklahoma, 74136, United States
CCOP - Columbia River Program
Portland Oregon, 97213, United States
Legacy Emanuel Hospital and Health Center
Portland Oregon, 97227, United States
St. Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Children's Hospital of Greenville Hospital System
Greenville South Carolina, 29605, United States
James H. Quillen College of Medicine
Johnson City Tennessee, 37614, United States
Saint Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Driscoll Children's Hospital
Corpus Christi Texas, 78466, United States
Texas Oncology P.A.
Dallas Texas, 75230, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
Cook Children's Medical Center - Fort Worth
Fort Worth Texas, 76104, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Baylor College of Medicine
Houston Texas, 77030, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base Texas, 78236, United States
MBCCOP - South Texas Pediatric
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Scott and White Clinic
Temple Texas, 76508, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
Cancer Center at the University of Virginia
Charlottesville Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Naval Medical Center, Portsmouth
Portsmouth Virginia, 23708, United States
Massey Cancer Center
Richmond Virginia, 23298, United States
Carilion Roanoke Community Hospital
Roanoke Virginia, 24029, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
West Virginia University Medical School-Charleston
Charleston West Virginia, 25304, United States
West Virginia University Hospitals
Morgantown West Virginia, 26506, United States
St. Vincent Hospital
Green Bay Wisconsin, 54307, United States
Midwest Children's Cancer Center
Milwaukee Wisconsin, 53226, United States
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Alberta Children's Hospital
Calgary Alberta, T2T 5, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Children's Hospital
Hamilton Ontario, L8N 3, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal Quebec, H3H 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada
Centre Hospitalier de L'Universite Laval
Sainte Foy Quebec, GIV 4, Canada
Laval University Medical Center
Sainte-Foy Quebec, G1V 4, Canada
Academisch Ziekenhuis Groningen
Groningen , 9713 , Netherlands
San Jorge Childrens Hospital
Santurce , 00912, Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern , CH 30, Switzerland
Clinique de Pediatrie
Geneva , 1211, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne , CH-10, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00009698

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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