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| 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 |
| Estimated Enrollment: | 27 |
| Study Start Date: | March 1998 |
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 |
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
Hide Study 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 | |
| Study Chair: | Kimo C. Stine, MD | Arkansas Children's Hospital at the University of Arkansas for Medical Sciences |
More Information
| 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 |
|
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) |
|
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 |