Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia
- Registration Number
- NCT00003671
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.
- Detailed Description
OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in children with average risk acute lymphocytic leukemia. II. Determine the feasibility of delivering 6 courses of this therapy in these patients.
OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion, methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24 until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks 8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29, daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21, and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48 hours after the start of oral methotrexate. Patients also receive methotrexate IT during week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another continuation: Patients receive oral methotrexate once weekly except during the week of methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment continues for up to 130 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually for ten years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy Treatment dexamethasone See detailed description. Chemotherapy Treatment daunorubicin hydrochloride See detailed description. Chemotherapy Treatment leucovorin calcium See detailed description. Chemotherapy Treatment vincristine sulfate See detailed description. Chemotherapy Treatment thioguanine See detailed description. Chemotherapy Treatment asparaginase See detailed description. Chemotherapy Treatment cyclophosphamide See detailed description. Chemotherapy Treatment cytarabine See detailed description. Chemotherapy Treatment mercaptopurine See detailed description. Chemotherapy Treatment methotrexate See detailed description.
- Primary Outcome Measures
Name Time Method Event-free survival 7 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Maine Children's Cancer Program
🇺🇸Portland, Maine, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
West Virginia University Medical School, Charleston Division
🇺🇸Charleston, West Virginia, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Christ Hospital
🇺🇸Oak Lawn, Illinois, United States
Via Christi Regional Medical Center-Saint Francis Campus
🇺🇸Wichita, Kansas, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics
🇺🇸Columbia, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
University of New Mexico School of Medicine
🇺🇸Albuquerque, New Mexico, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Scott and White Clinic
🇺🇸Temple, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
St. John's Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Oklahoma Memorial Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
San Jorge Childrens Hospital
🇵🇷Santurce, Puerto Rico
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Centre Hospitalier de L'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Clinique de Pediatrie
🇨🇭Geneva, Switzerland
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
James H. Quillen College of Medicine
🇺🇸Johnson City, Tennessee, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Walt Disney Memorial Cancer Institute
🇺🇸Orlando, Florida, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States