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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 114 Locations for this study
Birmingham Alabama, 35294, United States
Mobile Alabama, 36617, United States
Mobile Alabama, 36688, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72202, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92093, United States
Palo Alto California, 94304, United States
Sacramento California, 95816, United States
Sacramento California, 95817, United States
San Diego California, 92120, United States
San Diego California, 92123, United States
Santa Clara California, 95051, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20307, United States
Fort Lauderdale Florida, 33316, United States
Fort Myers Florida, 33908, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
Miami Florida, 33136, United States
Miami Florida, 33155, United States
Miami Florida, 33176, United States
Orlando Florida, 32803, United States
St. Petersburg Florida, 33701, United States
Tampa Florida, 33682, United States
West Palm Beach Florida, 33407, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96859, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60614, United States
Oak Lawn Illinois, 60453, United States
Peoria Illinois, 61602, United States
Peoria Illinois, 61637, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Bangor Maine, 04401, United States
Portland Maine, 04101, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48236, United States
Flint Michigan, 48503, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Columbia Missouri, 65212, United States
Saint Louis Missouri, 63104, United States
Saint Louis Missouri, 63110, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87131, United States
Buffalo New York, 14263, United States
New Hyde Park New York, 11042, United States
New York New York, 10029, United States
Rochester New York, 14642, United States
Stony Brook New York, 11790, United States
Syracuse New York, 13210, United States
Asheville North Carolina, 28801, United States
Charlotte North Carolina, 28232, United States
Charlotte North Carolina, 28233, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27157, United States
Oklahoma City Oklahoma, 73126, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97213, United States
Portland Oregon, 97227, United States
Philadelphia Pennsylvania, 19134, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Johnson City Tennessee, 37614, United States
Memphis Tennessee, 38105, United States
Corpus Christi Texas, 78466, United States
Dallas Texas, 75230, United States
Dallas Texas, 75230, United States
Dallas Texas, 75235, United States
Fort Worth Texas, 76104, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Lackland Air Force Base Texas, 78236, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78284, United States
Temple Texas, 76508, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Falls Church Virginia, 22042, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24029, United States
Tacoma Washington, 98431, United States
Charleston West Virginia, 25304, United States
Morgantown West Virginia, 26506, United States
Green Bay Wisconsin, 54307, United States
Milwaukee Wisconsin, 53226, United States
Parkville Victoria, 3052, Australia
Calgary Alberta, T2T 5, Canada
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8N 3, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3H 1, Canada
Montreal Quebec, H3T 1, Canada
Sainte Foy Quebec, GIV 4, Canada
Sainte-Foy Quebec, G1V 4, Canada
Groningen , 9713 , Netherlands
Santurce , 00912, Puerto Rico
Bern , CH 30, Switzerland
Geneva , 1211, Switzerland
Lausanne , CH-10, Switzerland
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.