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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Alberta
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Calgary, Alberta, Canada, T2T 5C7
- Alberta Children's Hospital
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital
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Sainte Foy, Quebec, Canada, GIV 4G2
- Centre Hospitalier de l'Université Laval
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Groningen, Nederland, 9713 EZ
- Academisch Ziekenhuis Groningen
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Santurce, Puerto Rico, 00912
- San Jorge Childrens Hospital
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Arizona
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Tucson, Arizona, Verenigde Staten, 85724
- Arizona Cancer Center
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California
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Palo Alto, California, Verenigde Staten, 94304
- Lucile Packard Children's Hospital at Stanford
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Sacramento, California, Verenigde Staten, 95816
- Sutter Cancer Center
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San Diego, California, Verenigde Staten, 92120
- Kaiser Permanente-Southern California Permanente Medical Group
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San Diego, California, Verenigde Staten, 92134-3202
- Naval Medical Center - San Diego
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Santa Clara, California, Verenigde Staten, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Florida
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Jacksonville, Florida, Verenigde Staten, 32207
- Nemours Children's Clinic
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Miami, Florida, Verenigde Staten, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Verenigde Staten, 33176-2197
- Baptist Hospital of Miami
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Orlando, Florida, Verenigde Staten, 32803
- Walt Disney Memorial Cancer Institute
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West Palm Beach, Florida, Verenigde Staten, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96859-5000
- Tripler Army Medical Center
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, Verenigde Staten, 60614
- Children's Memorial Hospital, Chicago
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Oak Lawn, Illinois, Verenigde Staten, 60453
- Christ Hospital
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Peoria, Illinois, Verenigde Staten, 61602
- Saint Jude Midwest Affiliate
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Kansas
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Wichita, Kansas, Verenigde Staten, 67214
- Via Christi Regional Medical Center-Saint Francis Campus
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane University School of Medicine
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Maine
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Bangor, Maine, Verenigde Staten, 04401
- Eastern Maine Medical Center
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Portland, Maine, Verenigde Staten, 04101
- Maine Children's Cancer Program
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit, Michigan, Verenigde Staten, 48236
- St. John's Hospital and Medical Center
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, Verenigde Staten, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Columbia, Missouri, Verenigde Staten, 65212
- University of Missouri-Columbia Hospital and Clinics
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Saint Louis, Missouri, Verenigde Staten, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Norris Cotton Cancer Center
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87131
- University of New Mexico School of Medicine
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New York
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Stony Brook, New York, Verenigde Staten, 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, Verenigde Staten, 27710
- Duke Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73126-0307
- Oklahoma Memorial Hospital
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Tulsa, Oklahoma, Verenigde Staten, 74136
- Natalie Warren Bryant Cancer Center
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Tennessee
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Johnson City, Tennessee, Verenigde Staten, 37614-0622
- James H. Quillen College of Medicine
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Texas
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Dallas, Texas, Verenigde Staten, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Verenigde Staten, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, Verenigde Staten, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, Verenigde Staten, 77555-1329
- University of Texas Medical Branch
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Houston, Texas, Verenigde Staten, 77030
- Baylor College of Medicine
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Lackland Air Force Base, Texas, Verenigde Staten, 78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Temple, Texas, Verenigde Staten, 76508
- Scott and White Clinic
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Vermont
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Burlington, Vermont, Verenigde Staten, 05401-3498
- Vermont Cancer Center
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Virginia
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Falls Church, Virginia, Verenigde Staten, 22046
- INOVA Fairfax Hospital
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Roanoke, Virginia, Verenigde Staten, 24029
- Carilion Roanoke Memorial Hospital
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Washington
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Tacoma, Washington, Verenigde Staten, 98431-5000
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, Verenigde Staten, 25304
- West Virginia University Medical School, Charleston Division
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Morgantown, West Virginia, Verenigde Staten, 26506-9162
- West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Verenigde Staten, 54307-3508
- St. Vincent Hospital
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Midwest Children's Cancer Center
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Geneva, Zwitserland, 1211
- Clinique de Pediatrie
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Chemotherapy Treatment
See detailed description.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Event-free survival
Tijdsspanne: 7 years
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7 years
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Naomi J. Winick, MD, Simmons Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Leukemie
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Antivirale middelen
- Nucleïnezuursyntheseremmers
- Enzymremmers
- Ontstekingsremmende middelen
- Antireumatische middelen
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Anti-emetica
- Gastro-intestinale middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Beschermende middelen
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Dermatologische middelen
- Micronutriënten
- Antibiotica, antineoplastiek
- Vitaminen
- Reproductieve controlemiddelen
- Tegengif
- Vitamine B-complex
- Afbrekende middelen, niet-steroïde
- Abortieve agenten
- Foliumzuurantagonisten
- Dexamethason
- Cyclofosfamide
- Leucovorin
- Levoleucovorine
- Cytarabine
- Methotrexaat
- Vincristine
- Daunorubicine
- Asparaginase
- Mercaptopurine
- Thioguanine
Andere studie-ID-nummers
- 9705
- POG-9705 (Andere identificatie: Pediatric Oncology Group)
- CDR0000066768 (Andere identificatie: Clinical Trials.gov)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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product vervaardigd in en geëxporteerd uit de V.S.
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