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Spots Global Cancer Trial Database for Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

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Trial Identification

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

Conditions

Leukemia

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Zoann E. Dreyer, MD

Affiliation: Texas Children's Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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