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Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia

Official Title: A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia

Study ID: NCT00022126

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.

Detailed Description: OBJECTIVES: * Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster (BFM) consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia. * Determine the event-free survival of patients treated with this regimen. * Determine the clinical prognostic features associated with outcome in these patients. * Compare the biologic characteristics of the leukemia cells with outcome in these patients. OUTLINE: This is a multicenter study. Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14; daunorubicin IV on days 1, 8, and 15; vincristine IV on days 1, 8, 15, and 22; and asparaginase intramuscularly (IM) on days 4, 6, 8, 11, 13, 15, 18, 20, and 22. Patients also receive methotrexate intrathecally (IT) on days 1, 8, and 15 (and days 4 and 22 for overt CNS disease). Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover. Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 2-5, 9-12, 30-33, and 37-40; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, and 15. Patients who do not receive bone marrow transplantation (BMT) proceed to interim maintenance #1 when blood counts recover. Patients receive methotrexate IT on days 1, 11, 22, and 32; methotrexate IV and vincristine IV on days 1, 11, 22, 32, and 43; and pegaspargase IM on days 2 and 23. When blood counts recover, patients receive delayed intensification #1 comprising vincristine IV on days 1, 8, 15, 43, and 50; doxorubicin IV on days 1, 8, and 15; oral dexamethasone 3 times daily on days 1-7 and 15-21; pegaspargase IM on days 4 and 43; cyclophosphamide IV on day 29; methotrexate IT on days 29 and 36; oral thioguanine on days 29-42; and cytarabine IV or SC on days 30-33 and 37-40. When blood counts recover, patients receive interim maintenance #2 comprising vincristine as in interim maintenance #1; methotrexate IT on day 1 and IV on days 1, 11, 22, 32, and 41; and pegaspargase IM on days 2 and 23. When blood counts recover, patients receive delayed intensification #2 comprising vincristine, doxorubicin, dexamethasone, pegaspargase, cyclophosphamide, cytarabine, and thioguanine as in intensification #1. Patients also receive methotrexate IT on days 1 and 29. When blood counts recover, patients receive maintenance therapy comprising methotrexate IT on day 1 and orally on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; vincristine IV on days 1, 29, and 57; oral dexamethasone 3 times daily on days 1-5, 29-33, and 57-61; and oral mercaptopurine daily. Treatment repeats every 84 days for 6 courses. Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after receiving methotrexate IV during interim maintenance #1 and #2 and daily over 6 days in place of each dose of pegaspargase during delayed intensification #1 and #2. After augmented consolidation therapy, patients meeting the following criteria may receive BMT in place of chemotherapy: * In remission * Exhibiting chromosome translocation involving 11q23 or Ph+{(9;22)} * Available HLA-A, B, DR genotypic identical relative donor * No uncontrolled infection * Adequate organ function Within 3-4 weeks of consolidation therapy, patients undergoing allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5; cyclophosphamide IV over 30 minutes on days -7 and -6; and methylprednisolone IV twice daily on days -2 to 0. Patients also undergo total body irradiation twice daily on days -3 to 0. Patients receive allogeneic BMT on day 0. Patients also receive cyclosporine IV every 12 hours beginning on day -1, switching to oral when possible, and continuing until day 60. Patients then taper cyclosporine over the next 60-120 days. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1-2 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 20-40 patients will be accrued for this study within 2 years.

Eligibility

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

Phoenix Children's Hospital, Phoenix, Arizona, United States

Loma Linda University Medical Center, Loma Linda, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Children's Hospital Central California, Madera, California, United States

Children's Hospital of Oakland, Oakland, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, United States

Children's Hospital of Orange County, Orange, California, United States

Children's Hospital of Denver, Denver, Colorado, United States

University of Connecticut Health Center, Farmington, Connecticut, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States

Children's National Medical Center, Washington, District of Columbia, United States

Emory University Hospital - Atlanta, Atlanta, Georgia, United States

Children's Healthcare of Atlanta - Scottish Rite, Atlanta, Georgia, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Children's Hospitals and Clinics - Minneapolis, Minneapolis, Minnesota, United States

Children's Hospitals and Clinics - Minnesota, Saint Paul, Minnesota, United States

Children's Mercy Hospital, Kansas City, Missouri, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Mount Sinai School of Medicine, New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, 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

Children's Hospital of Columbus, Columbus, Ohio, United States

Children's Medical Center - Dayton, Dayton, Ohio, United States

Doernbecher Children's Hospital, Portland, Oregon, United States

CCOP - Columbia River Oncology Program, Portland, Oregon, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Baylor College of Medicine, Houston, Texas, United States

Methodist Cancer Center, San Antonio, Texas, United States

CCOP - Scott and White Hospital, Temple, Texas, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

Deaconess Medical Center, Spokane, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States

Women's and Children's Hospital, North Adelaide, South Australia, Australia

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

IWK Health Centre, Halifax, Nova Scotia, Canada

Contact Details

Name: Paul S. Gaynon, MD

Affiliation: Children's Hospital Los Angeles

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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