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Brief Title: Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
Official Title: Induction Intensification in Infant ALL: A Children's Oncology Group Study
Study ID: NCT00002756
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells. PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.
Detailed Description: OBJECTIVES: Primary * Assess the feasibility of intensification with two courses of high-dose methotrexate followed by one course of cyclophosphamide/etoposide during induction and later as consolidation in infants with newly diagnosed acute lymphoblastic leukemia. * Determine event-free survival after shortened, intensive therapy in these patients. * Compare event-free survival rates of infants receiving this regimen whose leukemic blasts have or do not have translocations involving the 11q23 gene MLL. Secondary * Correlate the presence of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome. * Investigate the clinical prognostic features that may be associated with outcome in infants, such as bone marrow blast content at day 8, white blood cell count, and age. * Correlate biologic characteristics of the leukemia cells at diagnosis (protocol POG-9900) with outcome in patients treated with this regimen. * Characterize patterns of gene expression associated with host and disease characteristics and treatment response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to participating center and presence of CNS disease (yes vs no). Patients receive induction chemotherapy comprising vincristine IV on days 1, 8, and 15; oral prednisone three times a day on days 1-21; daunorubicin IV over 30 minutes on days 1-2; cyclophosphamide IV over 30 minutes every 12 hours on days 3-4; and asparaginase intramuscularly (IM) on days 4, 6, 8, 10, 12, 15, 17, and 19. Patients also receive triple intrathecal therapy comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, and 15 and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 5 and continuing until day 20, regardless of blood counts. Patients receive induction intensification chemotherapy comprising high-dose methotrexate IV over 24 hours; triple intrathecal therapy as per induction therapy on days 22 and 29; and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses. Patients also receive etoposide IV over 2 hours and cyclophosphamide IV over 30 minutes on days 36-40. Patients receive G-CSF SC or IV beginning on day 41 and continuing until blood counts recover. Patients achieving morphologic remission and recovery of blood counts while off G-CSF for 48 hours receive reinduction chemotherapy comprising the same regimen as in induction therapy with the exception of asparaginase IM beginning on day 1 (week 8) and continuing every Monday, Wednesday, and Friday for a total of 8 doses and triple intrathecal therapy on days 1 and 15 only (weeks 8 and 10). Patients receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. After blood count recovery, patients receive consolidation chemotherapy comprising triple intrathecal therapy as per induction therapy on day 1 (week 11); high-dose methotrexate IV over 24 hours on weeks 8 and 12; and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses. Patients also receive etoposide IV over 2 hours followed by cyclophosphamide IV over 30 minutes on days 15-19 (week 13). Patients receive G-CSF SC or IV beginning on day 20 and continuing until blood counts recover. On days 29-31 (week 15), patients receive high-dose cytarabine IV over 3 hours every 12 hours for 4 doses and asparaginase IM 6 hours after completion of high-dose cytarabine. Patients receive G-CSF beginning 24 hours after completion of asparaginase and continuing until blood counts recover. Patients achieving morphologic remission and blood count recovery while off G-CSF for 48 hours receive continuation therapy comprising vincristine IV on day 1; oral prednisone three times a day on days 1-5; and triple intrathecal therapy on day 1 (weeks 18 and 22). Patients also receive methotrexate IM once a week and oral mercaptopurine daily on weeks 19-21, 23, and 24. On week 25, patients receive etoposide IV over 2 hours daily followed by cyclophosphamide IV over 30 minutes daily on days 1-5 and G-CSF SC or IV beginning on day 6 and continuing until blood counts recover. Patients receive an additional course of continuation therapy on weeks 28-35. On weeks 38-48, patients receive another identical course of continuation therapy with the exclusion of the etoposide and cyclophosphamide combination regimen. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: Approximately 58-104 patients will be accrued for this study within 2.1 years.
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital and Research Center - Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
Sutter Cancer Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States
Children's Hospital and Health Center - San Diego, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Santa Barbara Cottage Children's Hospital, Santa Barbara, California, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, United States
Yale Cancer Center, New Haven, Connecticut, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States
Broward General Medical Center Cancer Center, Ft. Lauderdale, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Baptist-South Miami Regional Cancer Program, Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
St. Luke's Mountain States Tumor Institute - Boise, Boise, Idaho, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Children's Hospital of New Orleans, New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States
Children's Hospitals and Clinics of Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Medical Center - Fairview, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base, Keesler AFB, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital, St. Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Maimonides Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Winthrop University Hospital, Mineola, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
Tod Children's Hospital - Forum Health, Youngstown, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Greenville Hospital System Cancer Center, Greenville, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
INOVA Fairfax Hospital, Fairfax, Virginia, United States
Children's Hospital of the King's Daughters, Norfolk, Virginia, United States
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States
Carilion Cancer Center of Western Virginia, Roanoke, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva, Geneva, , Switzerland
Swiss Pediatric Oncology Group Lausanne, Lausanne, , Switzerland
Name: Zoann E. Dreyer, MD
Affiliation: Texas Children's Cancer Center
Role: STUDY_CHAIR