Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
NCT ID: NCT00003783
Last Updated: 2014-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
1999-03-31
2007-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.
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Detailed Description
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OUTLINE: Patients receive induction therapy on weeks 1-4. This consists of oral prednisone three times a day on days 1-28; vincristine IV on days 1, 8, 15, and 22; daunorubicin IV on days 8, 15, and 22; and asparaginase IM on days 2, 5, 8, 12, 15, and 19. Patients also receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS 2 and 3 disease also receive methotrexate IT on days 15 and 22. Patients who achieve M2 bone marrow on day 29 receive oral prednisone three times a day 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. If bone marrow is M3 on day 29 or M2 or M3 on day 43, then patient is off study. Patients proceed to consolidation therapy on weeks 5-25. This consists of high dose methotrexate IV over 24 hours on weeks 6, 8, 16, and 18, followed by leucovorin calcium IV or orally every 6 hours for 5 doses; oral mercaptopurine on weeks 6-9 and 16-19; cytarabine IV over 6 hours followed by idarubicin IV over 15 minutes for 4 days; and filgrastim (G-CSF) subcutaneously (SQ) beginning on day 5 and continuing for about 10-14 days on weeks 10 and 20. Patients receive etoposide IV over 1 hour followed by cyclophosphamide IV over 10 minutes for 5 days and G-CSF SQ beginning on day 6 for 10-14 days on weeks 13 and 23. Methotrexate IT is administered on weeks 6, 8, 13, 16, 18, and 23. Patients then proceed to continuous intensification therapy during weeks 26-61. Patients receive vincristine IV, daunorubicin IV, and methotrexate IT on day 1, and oral dexamethasone twice a day on days 1-7 on weeks 26, 32, 38, 44, 50, and 56. Patients also receive high dose cytarabine IV over 1 hour, every 12 hours, for 4 doses, followed by asparaginase IM 3 hours after the last dose of cytarabine, on weeks 27, 33, 39, 45, 51, and 57. Oral mercaptopurine and methotrexate IM are administered on day 1 during weeks 29, 31, 35, 37, 41, 43, 47, 49, 53, 55, 59, and 61. Patients receive etoposide IV over 1-2 hours followed by cyclophosphamide IV during weeks 30, 36, 42, 48, 54, and 60. Patients then proceed to continuation therapy during weeks 62-126. Vincristine IV and cyclophosphamide IV are administered on weeks 62-65, 70-73, 78-81, 86-89, 94-97, 102-105, 110-113, and 118-121. Patients also receive oral dexamethasone twice a day for 7 days on weeks 62, 70, 78, 86, 94, 102, 110, and 118, and cytarabine IV on weeks 63, 65, 71, 73, 79, 81, 87, 89, 95, 97, 103, 105, 111, 113, 119, and 121. Oral mercaptopurine is administered daily during weeks 66-69, 74-77, 82-85, 90-93, 98-101, 106-109, 114-117, and 122-125 and methotrexate IM on weeks 66-69, 74-77, 82-85, 90-93, 98-101, 106-109, 114-117, and 122-125. Methotrexate IT is administered during weeks 62, 70, 78, 86, 94, 102, 110, and 118. Patients who are CNS 3 at diagnosis receive whole brain irradiation beginning at week 62 along with the first course of continuation therapy. These patients do not receive any methotrexate IT after week 62. 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, then annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 12 months.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Complete Response and no CNS 3
See detailed description.
filgrastim
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
etoposide
idarubicin
leucovorin calcium
mercaptopurine
methotrexate
prednisone
vincristine sulfate
radiation therapy
Complete Response and CNS 3
See detailed description.
filgrastim
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
etoposide
idarubicin
leucovorin calcium
mercaptopurine
methotrexate
prednisone
vincristine sulfate
radiation therapy
Interventions
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filgrastim
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
etoposide
idarubicin
leucovorin calcium
mercaptopurine
methotrexate
prednisone
vincristine sulfate
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: See Disease Characteristics
17 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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William P. Bowman, MD
Role: STUDY_CHAIR
Cook Children's Medical Center - Fort Worth
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States
St. Mary's Hospital
West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
Hope Children's Hospital
Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Tulane University School of Medicine
New Orleans, Louisiana, 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
St. John's Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, 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
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
James H. Quillen College of Medicine
Johnson City, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer 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 College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
Scott and White Clinic
Temple, Texas, United States
Vermont Cancer Center
Burlington, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Carilion Roanoke Community Hospital
Roanoke, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University Medical School, Charleston Division
Charleston, West Virginia, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, Canada
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
San Jorge Childrens Hospital
Santurce, , Puerto Rico
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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Other Identifiers
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POG-9806
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066915
Identifier Type: OTHER
Identifier Source: secondary_id
9806
Identifier Type: -
Identifier Source: org_study_id
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