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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) of IL-2
2 years
Yes
Kimo C. Stine, MD
Study Chair
Arkansas Children's Hospital at the University of Arkansas for Medical Sciences
United States: Federal Government
9674
NCT00009698
March 1998
September 2005
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Arizona Cancer Center | Tucson, Arizona 85724 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of Rochester Cancer Center | Rochester, New York 14642 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of California Davis Medical Center | Sacramento, California 95817 |
Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
CCOP - Florida Pediatric | Tampa, Florida 33682-7757 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
Mount Sinai School of Medicine | New York, New York 10029 |
Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
Oklahoma Memorial Hospital | Oklahoma City, Oklahoma 73126-0307 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
Baptist Hospital of Miami | Miami, Florida 33176-2197 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Sutter Cancer Center | Sacramento, California 95816 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
University of South Alabama Medical Center | Mobile, Alabama 36604 |
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Children's Hospital of Southwest Florida | Fort Myers, Florida 33908 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
St. Mary's Hospital | West Palm Beach, Florida 33407 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
University of Missouri-Columbia Hospital and Clinics | Columbia, Missouri 65212 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
Schneider Children's Hospital | New Hyde Park, New York 11042 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
Lucile Packard Children's Hospital at Stanford | Palo Alto, California 94304 |
Hope Children's Hospital | Oak Lawn, Illinois 60453 |
Mission Saint Joseph's Health System | Asheville, North Carolina 28801 |
Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Children's Hospital and Health Center | San Diego, California 92123-4282 |
Children's Memorial Hospital, Chicago | Chicago, Illinois 60614 |
MBCCOP - South Texas Pediatric | San Antonio, Texas 78284-7810 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
Arkansas Children's Hospital | Little Rock, Arkansas 72202-3591 |
Scott and White Clinic | Temple, Texas 76508 |
James H. Quillen College of Medicine | Johnson City, Tennessee 37614-0622 |
Carilion Roanoke Community Hospital | Roanoke, Virginia 24013 |
University of Miami-Jackson Memorial Hospital Medical Center | Miami, Florida 33136 |
Walt Disney Memorial Cancer Institute | Orlando, Florida 32803 |
University of New Mexico School of Medicine | Albuquerque, New Mexico 87131 |
St. John's Hospital and Medical Center | Detroit, Michigan 48236 |
West Virginia University Medical School-Charleston | Charleston, West Virginia 25304 |
Texas Oncology P.A. | Dallas, Texas 75230-2503 |