Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia
Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Arizona
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Tucson, Arizona, Förenta staterna, 85724
- Arizona Cancer Center
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California
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Palo Alto, California, Förenta staterna, 94304
- Lucile Packard Children's Hospital at Stanford
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Sacramento, California, Förenta staterna, 95816
- Sutter Cancer Center
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San Diego, California, Förenta staterna, 92120
- Kaiser Permanente-Southern California Permanente Medical Group
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San Diego, California, Förenta staterna, 92134-3202
- Naval Medical Center - San Diego
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Santa Clara, California, Förenta staterna, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Florida
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Jacksonville, Florida, Förenta staterna, 32207
- Nemours Children's Clinic
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Miami, Florida, Förenta staterna, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Förenta staterna, 33176-2197
- Baptist Hospital of Miami
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Orlando, Florida, Förenta staterna, 32803
- Walt Disney Memorial Cancer Institute
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West Palm Beach, Florida, Förenta staterna, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96859-5000
- Tripler Army Medical Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, Förenta staterna, 60614
- Children's Memorial Hospital, Chicago
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Oak Lawn, Illinois, Förenta staterna, 60453
- Christ Hospital
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Peoria, Illinois, Förenta staterna, 61602
- Saint Jude Midwest Affiliate
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Kansas
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Regional Medical Center-Saint Francis Campus
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane University School of Medicine
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Maine
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Bangor, Maine, Förenta staterna, 04401
- Eastern Maine Medical Center
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Portland, Maine, Förenta staterna, 04101
- Maine Children's Cancer Program
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit, Michigan, Förenta staterna, 48236
- St. John's Hospital and Medical Center
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, Förenta staterna, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Columbia, Missouri, Förenta staterna, 65212
- University of Missouri-Columbia Hospital and Clinics
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Saint Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- Norris Cotton Cancer Center
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87131
- University of New Mexico School of Medicine
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New York
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Stony Brook, New York, Förenta staterna, 11790-9832
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73126-0307
- Oklahoma Memorial Hospital
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Tulsa, Oklahoma, Förenta staterna, 74136
- Natalie Warren Bryant Cancer Center
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Tennessee
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Johnson City, Tennessee, Förenta staterna, 37614-0622
- James H. Quillen College of Medicine
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Texas
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Dallas, Texas, Förenta staterna, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Förenta staterna, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, Förenta staterna, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, Förenta staterna, 77555-1329
- University of Texas Medical Branch
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine
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Lackland Air Force Base, Texas, Förenta staterna, 78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Temple, Texas, Förenta staterna, 76508
- Scott and White Clinic
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Vermont
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Burlington, Vermont, Förenta staterna, 05401-3498
- Vermont Cancer Center
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Virginia
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Falls Church, Virginia, Förenta staterna, 22046
- INOVA Fairfax Hospital
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Roanoke, Virginia, Förenta staterna, 24029
- Carilion Roanoke Memorial Hospital
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Washington
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Tacoma, Washington, Förenta staterna, 98431-5000
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, Förenta staterna, 25304
- West Virginia University Medical School, Charleston Division
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Morgantown, West Virginia, Förenta staterna, 26506-9162
- West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Förenta staterna, 54307-3508
- St. Vincent Hospital
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Midwest Children's Cancer Center
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Alberta
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Calgary, Alberta, Kanada, T2T 5C7
- Alberta Children's Hospital
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Ontario
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Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- Montreal Children's Hospital
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Sainte Foy, Quebec, Kanada, GIV 4G2
- Centre Hospitalier de l'Université Laval
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Groningen, Nederländerna, 9713 EZ
- Academisch Ziekenhuis Groningen
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Santurce, Puerto Rico, 00912
- San Jorge Childrens Hospital
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Geneva, Schweiz, 1211
- Clinique de Pediatrie
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS: Histologically newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for induction therapy Average prognosis (neither very good nor very poor)
PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Chemotherapy Treatment
See detailed description.
|
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Event-free survival
Tidsram: 7 years
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7 years
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Naomi J. Winick, MD, Simmons Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Leukemi
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antivirala medel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Antiinflammatoriska medel
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Skyddsmedel
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Dermatologiska medel
- Mikronäringsämnen
- Antibiotika, antineoplastiska
- Vitaminer
- Reproduktionskontrollmedel
- Motgift
- Vitamin B-komplex
- Abortframkallande medel, icke-steroida
- Abortmedel
- Folsyraantagonister
- Dexametason
- Cyklofosfamid
- Leucovorin
- Levoleucovorin
- Cytarabin
- Metotrexat
- Vincristine
- Daunorubicin
- Asparaginas
- Merkaptopurin
- Tioguanin
Andra studie-ID-nummer
- 9705
- POG-9705 (Annan identifierare: Pediatric Oncology Group)
- CDR0000066768 (Annan identifierare: Clinical Trials.gov)
Läkemedels- och apparatinformation, studiedokument
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