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IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial


Phase 1
N/A
21 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of IL-2

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Kimo C. Stine, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Arkansas Children's Hospital at the University of Arkansas for Medical Sciences

Authority:

United States: Federal Government

Study ID:

9674

NCT ID:

NCT00009698

Start Date:

March 1998

Completion Date:

September 2005

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Mount Sinai School of MedicineNew York, New York  10029
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Columbia River ProgramPortland, Oregon  97213
University of Texas Medical BranchGalveston, Texas  77555-1329
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Eastern Maine Medical CenterBangor, Maine  04401
Hackensack University Medical CenterHackensack, New Jersey  07601
University of South Alabama Medical CenterMobile, Alabama  36604
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Broward General Medical CenterFort Lauderdale, Florida  33316
Children's Hospital of Southwest FloridaFort Myers, Florida  33908
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
St. Mary's HospitalWest Palm Beach, Florida  33407
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Via Christi Regional Medical CenterWichita, Kansas  67214
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Hope Children's HospitalOak Lawn, Illinois  60453
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Hospital and Health CenterSan Diego, California  92123-4282
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
Scott and White ClinicTemple, Texas  76508
James H. Quillen College of MedicineJohnson City, Tennessee  37614-0622
Carilion Roanoke Community HospitalRoanoke, Virginia  24013
University of Miami-Jackson Memorial Hospital Medical CenterMiami, Florida  33136
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
St. John's Hospital and Medical CenterDetroit, Michigan  48236
West Virginia University Medical School-CharlestonCharleston, West Virginia  25304
Texas Oncology P.A.Dallas, Texas  75230-2503