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Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
This study is ongoing, but not recruiting participants.
First Received: February 2, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Pediatric Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00009698
  Purpose

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.


Condition Intervention Phase
Leukemia
Biological: aldesleukin
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 27
Study Start Date: March 1998
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009698

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617-2293
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Children's Hospital and Health Center
San Diego, California, United States, 92123-4282
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Sutter Cancer Center
Sacramento, California, United States, 95816
University of California Davis Medical Center
Sacramento, California, United States, 95817
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Miami Children's Hospital
Miami, Florida, United States, 33155
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
St. Mary's Hospital
West Palm Beach, Florida, United States, 33407
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
University of Miami-Jackson Memorial Hospital Medical Center
Miami, Florida, United States, 33136
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States, 32803
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Portland, Maine, United States, 04101
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Hurley Medical Center
Flint, Michigan, United States, 48503
St. John's Hospital and Medical Center
Detroit, Michigan, United States, 48236
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Mission Saint Joseph's Health System
Asheville, North Carolina, United States, 28801
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233-3549
United States, Oklahoma
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States, 73126-0307
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, South Carolina
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
James H. Quillen College of Medicine
Johnson City, Tennessee, United States, 37614-0622
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Scott and White Clinic
Temple, Texas, United States, 76508
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78466
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States, 78229-3900
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236-5300
Baylor College of Medicine
Houston, Texas, United States, 77030
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Texas Oncology P.A.
Dallas, Texas, United States, 75230-2503
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Carilion Roanoke Community Hospital
Roanoke, Virginia, United States, 24029
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
West Virginia University Medical School-Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier de L'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Laval University Medical Center
Sainte-Foy, Quebec, Canada, G1V 4G2
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Netherlands
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
Puerto Rico
San Jorge Childrens Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Clinique de Pediatrie
Geneva, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Pediatric Oncology Group
Investigators
Study Chair: Kimo C. Stine, MD Arkansas Children's Hospital at the University of Arkansas for Medical Sciences
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065574, POG-9674
Study First Received: February 2, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00009698     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Antineoplastic Agents
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2009