Chemotherapy |
Cancer Chemotherapy |
Clinical Trial: Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is currently recruiting patients.
Purpose
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. It is not yet known which regimen of chemotherapy is more effective for acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is comparing four regimens of combination chemotherapy to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| untreated childhood acute lymphoblastic leukemia | Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin Drug: dexamethasone Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: thioguanine Drug: vincristine Procedure: chemotherapy | Phase III |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Multidrug Delayed-Intensification Therapy in Children With Newly Diagnosed Standard-Risk Acute Lymphocytic Leukemia: An ALinC #17 Study
OBJECTIVES:
- Determine if multidrug delayed-intensification therapy improves outcome in children with newly diagnosed standard-risk acute lymphocytic leukemia.
- Compare the efficacy and toxicity of methotrexate administered over 4 hours vs methotrexate administered over 24 hours in this patient population.
- Determine the correlation between event-free survival, minimal residual disease, and early response in this patient population treated with this multiple drug regimen.
OUTLINE: This is a randomized, multicenter study.
- Induction (weeks 1-4): Patients receive induction therapy on POG 9900.
- Patients are randomized to one of four treatment arms. Patients with t(1;19) are randomized to either arm III or arm IV.
- Arm I (weeks 5-24): Patients receive IT methotrexate (MTX) on day 1 followed by MTX IV over 20 minutes followed by MTX continuously over 23.6 hours on weeks 7, 10, 13, 16,19, and 22. At 42 hours after the beginning of the MTX infusion, patients receive oral leucovorin calcium every 6 hours for a total of 3 doses. Patients also receive oral mercaptopurine daily beginning on week 5 and continuing until the completion of consolidation therapy; oral dexamethasone twice daily on days 1-7 of weeks 8 and 17; and vincristine IV on day 1 of weeks 8, 9, 17, and 18.
- Arm II (weeks 5-24): Patients receive MTX IV over 4 hours on weeks 7, 10, 13, 16, 19, and 22. At 42 hours after the beginning of the MTX infusion, patients receive oral leucovorin calcium as in arm I. Patients also receive mercaptopurine, dexamethasone, vincristine, and IT MTX as in arm I.
- Arm III (weeks 5-32): Patients receive MTX IV as in arm I on weeks 7, 10, 13, 24, 27, and 30; leucovorin calcium as in arm I; pegaspargase IM on day 2, 3, OR 4 of week 16; and oral mercaptopurine daily on weeks 5-13, and from week 24 until the completion of consolidation therapy. Patients also receive IT MTX as in arm I on weeks 7, 10, 13, 16, 20, 21, and 30; oral dexamethasone twice daily on weeks 8, 16-18, and 28 for a total of 35 days; vincristine IV on day 1 of weeks 8, 9, 16, 17, 18, 28, and 29; daunorubicin IV on day 1 of weeks 16-18; cyclophosphamide IV over 30 minutes on day 1 of week 20; cytarabine IV or subcutaneously daily on days 2-5 of weeks 20 and 21; and oral thioguanine daily on weeks 20-21.
- Arm IV (weeks 5-32): Patients receive MTX IV as in arm II on weeks 7, 10, 13, 24, 27, and 30; leucovorin calcium as in arm I; and pegaspargase, mercaptopurine, IT MTX, dexamethasone, vincristine, daunorubicin, cyclophosphamide, cytarabine, and thioguanine as in arm III.
- Intensive continuation (weeks 25-80): At weeks 25-72 for arms I and II, and at weeks 33-80 for arms III and IV, patients receive oral MTX every 6 hours for 4 doses on weeks 1, 3, 5, 7, 9, and 11; oral mercaptopurine daily; oral leucovorin calcium every 12 hours for 2 doses beginning 48 hours after the start of MTX; IT MTX and vincristine IV on day 1 of week 12; and oral dexamethasone twice daily on days 1-7, beginning with the administration of vincristine. Treatment repeats every 12 weeks for 4 courses.
- Additional continuation (weeks 73-130): At weeks 73-130 for arms I and II, and at weeks 81-130 for arms III and IV, patients receive oral MTX weekly; oral mercaptopurine daily; vincristine IV on day 1 every 12 weeks; oral dexamethasone as during intensive continuation therapy; and IT MTX on day 1 every 12 weeks, beginning with the last week of the first course (in place of oral MTX). 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 every 6-12 months for 1 year.
PROJECTED ACCRUAL: A total of 1,014 patients will be accrued for this study within 3.22 years.
Eligibility
Ages Eligible for Study: 1 Year - 21 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of newly diagnosed B-precursor acute lymphocytic leukemia
- Standard risk (not low, high, or very high risk)
- Prior registration and treatment on POG 9900 Classification Study
PATIENT CHARACTERISTICS: Age:
- 1 to 21 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Location and Contact Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35233, United States; Recruiting
University of South Alabama Cancer Research Institute, Mobile, Alabama, 36604, United States; Recruiting
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
California
Children's Hospital and Health Center, San Diego, San Diego, California, 92123-4282, United States; Recruiting
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051-5386, United States; Recruiting
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, 92120, United States; Recruiting
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Stanford Cancer Center at Stanford University Medical Center, Palo Alto, California, 94304-1812, United States; Recruiting
Sutter Cancer Center, Sacramento, California, 95816, United States; Recruiting
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
Connecticut
Yale Comprehensive Cancer Center, New Haven, Connecticut, 06520-8064, United States; Recruiting
Florida
All Children's Hospital, St. Petersburg, Florida, 33701, United States; Recruiting
Baptist-South Miami Regional Cancer Program, Miami, Florida, 33176-2197, United States; Recruiting
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Children's Hospital of Southwest Florida, Fort Myers, Florida, 33908, United States; Recruiting
Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States; Recruiting
Joe DiMaggio Children's Hospital at Memorial, Hollywood, Florida, 33021, United States; Recruiting
Miami Children's Hospital, Miami, Florida, 33155, United States; Recruiting
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States; Recruiting
Nemours Children's Clinic-Orlando, Orlando, Florida, 32806, United States; Recruiting
Sacred Heart Children's Hospital, Pensacola, Florida, 32504, United States; Recruiting
St. Joseph's Children's Hospital, Tampa, Florida, 33677-4227, United States; Recruiting
St. Mary's Hospital, West Palm Beach, Florida, 33407, United States; Recruiting
University of Florida Shands Cancer Center, Gainesville, Florida, 32610-0296, United States; Recruiting
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, 30101, United States; Recruiting
Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, 30342, United States; Recruiting
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, 30912-4000, United States; Recruiting
Hawaii
Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Tripler Army Medical Center, Honolulu, Hawaii, 96859-5000, United States; Recruiting
Illinois
Advocate Hope Children's Hospital, Oak Lawn, Illinois, 60453, United States; Recruiting
Children's Memorial Hospital - Chicago, Chicago, Illinois, 60614, United States; Recruiting
Rush University Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Saint Jude Midwest Affiliate, Peoria, Illinois, 61637, United States; Recruiting
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7357, United States; Recruiting
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, 67214, United States; Recruiting
Wesley Medical Center, Wichita, Kansas, 67214, United States; Recruiting
Louisiana
Children's Hospital of New Orleans, New Orleans, Louisiana, 70118, United States; Recruiting
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States; Recruiting
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Maine
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, 04401, United States; Recruiting
Maine Children's Cancer Program, Scarborough, Maine, 04074-9308, United States; Recruiting
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201-1595, United States; Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States; Recruiting
Walter Reed Army Medical Center, Silver Spring, Maryland, 20910, United States; Recruiting
Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Floating Hospital for Children, Boston, Massachusetts, 02111, United States; Recruiting
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114-2696, United States; Recruiting
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Michigan
Children's Hospital of Michigan, Detroit, Michigan, 48201, United States; Recruiting
Hurley Medical Center, Flint, Michigan, 48503, United States; Recruiting
Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit, Michigan, 48236, United States; Recruiting
Mississippi
Keesler Medical Center - Keesler Air Force Base, Keesler AFB, Mississippi, 39534-2511, United States; Recruiting
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Missouri
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, 63104, United States; Recruiting
St. Louis Children's Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States; Recruiting
New Jersey
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States; Recruiting
New Mexico
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, 87131, United States; Recruiting
New York
Beth Israel Medical Center - Singer Division, New York, New York, 10128, United States; Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, 11794, United States; Recruiting
Mount Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Schneider Children's Hospital, New Hyde Park, New York, 11042, United States; Recruiting
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
North Carolina
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, 28232-2861, United States; Recruiting
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1081, United States; Recruiting
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville, North Carolina, 27858-4354, United States; Recruiting
Mission Hospitals, Asheville, North Carolina, 28801, United States; Recruiting
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, 28233, United States; Recruiting
Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, 74136, United States; Recruiting
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Oregon
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, 97227, United States; Recruiting
Pennsylvania
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, 19134-1095, United States; Recruiting
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
South Carolina
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, 29605, United States; Recruiting
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425-0721, United States; Recruiting
Tennessee
East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City, Tennessee, 37614-0622, United States; Recruiting
St. Jude Children's Research Hospital, Memphis, Tennessee, 38105-2794, United States; Recruiting
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Center for Cancer Prevention and Care at Scott and White Clinic, Temple, Texas, 76508, United States; Recruiting
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, 76104, United States; Recruiting
Driscoll Children's Hospital, Corpus Christi, Texas, 78466, United States; Recruiting
MBCCOP - South Texas Pediatrics, San Antonio, Texas, 78229-3900, United States; Recruiting
Medical City Dallas Hospital, Dallas, Texas, 75230, United States; Recruiting
San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, 78236, United States; Recruiting
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-9063, United States; Recruiting
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital, Houston, Texas, 77030-2399, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78207, United States; Recruiting
University of Texas Medical Branch, Galveston, Texas, 77555-0209, United States; Recruiting
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Virginia
Cancer Center at the University of Virginia, Charlottesville, Virginia, 22908, United States; Recruiting
Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke, Virginia, 24029, United States; Recruiting
INOVA Fairfax Hospital, Falls Church, Virginia, 22042-3300, United States; Recruiting
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, 23298-0121, United States; Recruiting
Naval Medical Center, Portsmouth, Portsmouth, Virginia, 23708-5100, United States; Recruiting
Washington
Madigan Army Medical Center, Tacoma, Washington, 98431-0001, United States; Recruiting
West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, 26506-9300, United States; Recruiting
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, 25302, United States; Recruiting
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Midwest Children's Cancer Center, Milwaukee, Wisconsin, 53226, United States; Recruiting
St. Vincent Hospital, Green Bay, Wisconsin, 54307-9070, United States; Recruiting
Australia, New South Wales
Children's Hospital at Westmead, Westmead, New South Wales, 2145, Australia; Recruiting
Australia, Queensland
Royal Children's Hospital, Brisbane, Queensland, 4029, Australia; Recruiting
Australia, Victoria
Royal Children's Hospital, Parkville, Victoria, 3052, Australia; Recruiting
Canada, Alberta
Alberta Children's Hospital, Calgary, Alberta, T2T 5C7, Canada; Recruiting
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada; Recruiting
Canada, Ontario
Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada; Recruiting
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada; Recruiting
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, L8N 3Z5, Canada; Recruiting
Canada, Quebec
Centre de Recherche du Centre Hospitalier de l'Universite Laval, Sainte-Foy, Quebec, GIV 4G2, Canada; Recruiting
Hopital Sainte Justine, Montreal, Quebec, H3T 1C5, Canada; Recruiting
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, H3G 1A4, Canada; Recruiting
Netherlands
University Medical Center Groningen, Groningen, 9700 RB, Netherlands; Recruiting
Puerto Rico
San Jorge Children's Hospital, Santurce, 00912, Puerto Rico; Recruiting
Switzerland
Swiss Pediatric Oncology Group Bern, Bern, CH 3010, Switzerland; Recruiting
Swiss Pediatric Oncology Group Geneva, Geneva, CH 1211, Switzerland; Recruiting
Naomi J. Winick, MD, Study Chair, Simmons Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: October 2003
Last Updated: April 4, 2005
Record first received: May 2, 2000
ClinicalTrials.gov Identifier: NCT00005596
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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