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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005585 |
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 combination chemotherapy is more effective for childhood acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: thioguanine Drug: vincristine sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | ALINC #17 Treatment for Patients With Low Risk Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Phase III Study |
| Study Start Date: | April 2000 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell precursor acute lymphoblastic leukemia
Classified as low-risk:
At least one of the following present:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Comprehensive Cancer Center at University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| University of South Alabama Cancer Research Institute | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Children's Hospital and Health Center - San Diego | |
| San Diego, California, United States, 92123-4282 | |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | |
| Santa Clara, California, United States, 95051-5386 | |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | |
| San Diego, California, United States, 92120 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Palo Alto, California, United States, 94304-1812 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8064 | |
| United States, Florida | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176-2197 | |
| Broward General Medical Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Children's Hospital of Southwest Florida | |
| Fort Myers, Florida, United States, 33908 | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| Joe DiMaggio Children's Hospital at Memorial | |
| Hollywood, Florida, United States, 33021 | |
| Kaplan Cancer Center at St. Mary's Medical Center | |
| West Palm Beach, Florida, United States, 33407 | |
| Sacred Heart Children's Hospital | |
| Pensacola, Florida, United States, 32504 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Nemours Children's Clinic-Orlando | |
| Orlando, Florida, United States, 32806 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| St. Joseph's Children's Hospital of Tampa | |
| Tampa, Florida, United States, 33677-4227 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0296 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 30101 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | |
| Atlanta, Georgia, United States, 30342 | |
| MBCCOP-Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-4000 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| Advocate Hope Children's Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Saint Jude Midwest Affiliate | |
| Peoria, Illinois, United States, 61637 | |
| United States, Kansas | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Louisiana | |
| Children's Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70118 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| Tulane Cancer Center at Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Children's Cancer Program | |
| Scarborough, Maine, United States, 04074-9308 | |
| Pediatric Specialty Clinic at Eastern Maine Medical Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201-1595 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-7223 | |
| Walter Reed Army Medical Center | |
| Silver Spring, Maryland, United States, 20910 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Floating Hospital for Children | |
| Boston, Massachusetts, United States, 02111 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114-2696 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler Air Force Base | |
| Keesler AFB, Mississippi, United States, 39534-2511 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| St. Louis Children's Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Beth Israel Medical Center - Singer Division | |
| New York, New York, United States, 10128 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Long Island Cancer Center at Stony Brook University Hospital | |
| Stony Brook, New York, United States, 11794-8174 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1081 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Children's Hospital of Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| East Tennessee State University Cancer Center at Johnson City Medical Center | |
| Johnson City, Tennessee, United States, 37614-0622 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | |
| Lackland Air Force Base, Texas, United States, 78236 | |
| Center for Cancer Prevention and Care at Scott and White Clinic | |
| Temple, Texas, United States, 76508 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78466 | |
| MBCCOP - South Texas Pediatrics | |
| San Antonio, Texas, United States, 78229-3900 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390-9063 | |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |
| Houston, Texas, United States, 77030-2399 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0209 | |
| United States, Vermont | |
| Vermont Cancer Center at University of Vermont | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| Carilion Medical Center for Children at Roanoke Community Hospital | |
| Roanoke, Virginia, United States, 24029 | |
| INOVA Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Massey Cancer Center at Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298-0121 | |
| Naval Medical Center - Portsmouth | |
| Portsmouth, Virginia, United States, 23708-5100 | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-0001 | |
| United States, West Virginia | |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | |
| Morgantown, West Virginia, United States, 26506-9300 | |
| West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | |
| Charleston, West Virginia, United States, 25302 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54307-9070 | |
| Australia, New South Wales | |
| Children's Hospital at Westmead | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, Victoria | |
| Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T2T 5C7 | |
| Cross Cancer Institute at University of Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8S 4J9 | |
| Canada, Quebec | |
| Centre de Recherche du Centre Hospitalier de l'Universite Laval | |
| Sainte Foy, Quebec, Canada, GIV 4G2 | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Montreal Children's Hospital at McGill University Health Center | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9700 RB | |
| Puerto Rico | |
| San Jorge Children's Hospital | |
| Santurce, Puerto Rico, 00912 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, CH 3010 | |
| Swiss Pediatric Oncology Group Geneva | |
| Geneva, Switzerland, CH 1211 | |
| Study Chair: | Paul L. Martin, MD | Duke University |
More Information
| Study ID Numbers: | CDR0000067657, COG-P9904, POG-9904 |
| Study First Received: | May 2, 2000 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005585 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood acute lymphoblastic leukemia in remission B-cell childhood acute lymphoblastic leukemia |
|
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Pegaspargase Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Thioguanine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin Leukemia, Lymphoid Immunologic Factors |
