Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
14 lutego 2017 zaktualizowane przez: Children's Oncology Group
Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
- Lek: terapeutyczny hydrokortyzon
- Lek: siarczan winkrystyny
- Biologiczny: filgrastim
- Lek: cyclophosphamide
- Lek: cytarabine
- Lek: daunorubicin hydrochloride
- Lek: dexamethasone
- Lek: etoposide
- Lek: leucovorin calcium
- Lek: mercaptopurine
- Lek: methotrexate
- Lek: pegaspargase
- Promieniowanie: radiation therapy
Szczegółowy opis
OBJECTIVES:
Primary
- Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse.
- Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse.
- Determine the toxicity of these regimens in these patients.
Secondary
- Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens.
- Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens.
- Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients.
- Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients.
OUTLINE: This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).
- Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22.
NOTE: *The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose is reached, all subsequent doses of daunorubicin are omitted.
NOTE: **Patients with isolated testicular relapse receive ITT on day 1 only.
In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy.
Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36.
- Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover.
Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.
- Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT* on days 15, 36, 57, and 78.
NOTE: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.
- Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over 15 minutes on days 1, 8, and 15.
- Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover.
NOTE: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.
- Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM on days 1 and 15.
Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions.
- Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses.
Maintenance therapy for isolated testicular relapse:
- (Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.
- (Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses.
Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients.
All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment.
Patients are followed for survival.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
168
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Quebec, Kanada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Kanada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Kanada, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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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, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Auckland, Nowa Zelandia, 1
- Starship Children's Health
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Christchurch, Nowa Zelandia, 8140
- Christchurch Hospital
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85016-7710
- Phoenix Children's Hospital
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Tucson, Arizona, Stany Zjednoczone, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Stany Zjednoczone, 90027
- Southern California Permanente Medical Group
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Duarte, California, Stany Zjednoczone, 91010-3000
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Stany Zjednoczone, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Stany Zjednoczone, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Stany Zjednoczone, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Stany Zjednoczone, 90027
- Childrens Hospital Los Angeles
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Madera, California, Stany Zjednoczone, 93638-8762
- Children's Hospital Central California
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Oakland, California, Stany Zjednoczone, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Stany Zjednoczone, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Stany Zjednoczone, 95798
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Stany Zjednoczone, 95816
- Sutter Cancer Center
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Sacramento, California, Stany Zjednoczone, 95825
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Stany Zjednoczone, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Stany Zjednoczone, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Stany Zjednoczone, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Stany Zjednoczone, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Stany Zjednoczone, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Stany Zjednoczone, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Stany Zjednoczone, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Stany Zjednoczone, 32610-0232
- University of Florida Shands Cancer Center
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Hollywood, Florida, Stany Zjednoczone, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Stany Zjednoczone, 32207
- Nemours Children's Clinic
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Miami, Florida, Stany Zjednoczone, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Stany Zjednoczone, 33155
- Miami Children's Hospital
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Miami, Florida, Stany Zjednoczone, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Stany Zjednoczone, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Stany Zjednoczone, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Stany Zjednoczone, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Stany Zjednoczone, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Stany Zjednoczone, 33701
- All Children's Hospital
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Tampa, Florida, Stany Zjednoczone, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Stany Zjednoczone, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Stany Zjednoczone, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612-7243
- University of Illinois Cancer Center
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Maywood, Illinois, Stany Zjednoczone, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Oak Lawn, Illinois, Stany Zjednoczone, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, Stany Zjednoczone, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Stany Zjednoczone, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Stany Zjednoczone, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Stany Zjednoczone, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Stany Zjednoczone, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Stany Zjednoczone, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40232
- Kosair Children's Hospital
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Maine
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Bangor, Maine, Stany Zjednoczone, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Stany Zjednoczone, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Stany Zjednoczone, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Stany Zjednoczone, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Stany Zjednoczone, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Stany Zjednoczone, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Stany Zjednoczone, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Stany Zjednoczone, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Stany Zjednoczone, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Stany Zjednoczone, 64108
- Children's Mercy Hospital
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Stany Zjednoczone, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Stany Zjednoczone, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Stany Zjednoczone, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, Stany Zjednoczone, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Stany Zjednoczone, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Stany Zjednoczone, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Stany Zjednoczone, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Stany Zjednoczone, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Stany Zjednoczone, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, Stany Zjednoczone, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, Stany Zjednoczone, 11501
- Winthrop University Hospital
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New Hyde Park, New York, Stany Zjednoczone, 11040
- Schneider Children's Hospital
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New York, New York, Stany Zjednoczone, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Stany Zjednoczone, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Stany Zjednoczone, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Stany Zjednoczone, 11794-9446
- Stony Brook University Cancer Center
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Syracuse, New York, Stany Zjednoczone, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Stany Zjednoczone, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Stany Zjednoczone, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Stany Zjednoczone, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Stany Zjednoczone, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Stany Zjednoczone, 44308-1062
- Akron Children's Hospital
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Stany Zjednoczone, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Stany Zjednoczone, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Stany Zjednoczone, 45404-1815
- Dayton Children's - Dayton
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Toledo, Ohio, Stany Zjednoczone, 43614
- Medical University of Ohio Cancer Center
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Youngstown, Ohio, Stany Zjednoczone, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Stany Zjednoczone, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Bethlehem, Pennsylvania, Stany Zjednoczone, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Stany Zjednoczone, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Stany Zjednoczone, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Stany Zjednoczone, 37901
- East Tennessee Children's Hospital
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Nashville, Tennessee, Stany Zjednoczone, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Stany Zjednoczone, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, Stany Zjednoczone, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Stany Zjednoczone, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Stany Zjednoczone, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Stany Zjednoczone, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Stany Zjednoczone, 77030-2399
- Baylor University Medical Center - Houston
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San Antonio, Texas, Stany Zjednoczone, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Stany Zjednoczone, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Stany Zjednoczone, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Falls Church, Virginia, Stany Zjednoczone, 22042-3300
- INOVA Fairfax Hospital
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Roanoke, Virginia, Stany Zjednoczone, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Spokane, Washington, Stany Zjednoczone, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, Stany Zjednoczone, 25302
- West Virginia University Health Sciences Center - Charleston
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Morgantown, West Virginia, Stany Zjednoczone, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Stany Zjednoczone, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Gundersen Lutheran Center for Cancer and Blood
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Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Bern, Szwajcaria, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Szwajcaria, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Szwajcaria, 1011
- Swiss Pediatric Oncology Group Lausanne
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
1 rok do 29 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL)
- B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
- In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
First isolated CNS and/or testicular relapse
Isolated CNS relapse, as defined by 1 of the following:
- WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
Identifiable blasts AND 1 of the following:
- B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
- T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
- Isolated testicular relapse, defined as biopsy proven testicular involvement
- No Down syndrome
- No T-cell ALL or T-cell non-Hodgkin lymphoma
- No known optic nerve and/or retinal involvement
PATIENT CHARACTERISTICS:
Age
- 18 months to 29 years at relapse
Performance status
- Karnofsky 30-100% (for patients > 16 years of age) OR
- Lansky 30-100% (for patients ≤ 16 years of age)
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
Creatinine adjusted according to age as follows:
- No greater than 0.4 mg/dL (≤ 5 months)
- No greater than 0.5 mg/dL (6 months -11 months)
- No greater than 0.6 mg/dL (1 year-23 months)
- No greater than 0.8 mg/dL (2 years-5 years)
- No greater than 1.0 mg/dL (6 years-9 years)
- No greater than 1.2 mg/dL (10 years-12 years)
- No greater than 1.4 mg/dL (13 years and over [female])
- No greater than 1.5 mg/dL (13 years to 15 years [male])
- No greater than 1.7 mg/dL (16 years and over [male]) OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular
- Shortening fraction ≥ 27% by echocardiogram OR
- Ejection fraction ≥ 50% by MUGA
Other
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior bone marrow transplantation
Chemotherapy
- Prior total anthracycline dosage ≤ 360 mg/m^2
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior systemic therapy for concurrent extramedullary relapse
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: CNS Patients-Treatment (combination chemotherapy)
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
|
podane IV
Inne nazwy:
given subcutaneously (SC)
Inne nazwy:
IV over 15-30 minutes
Inne nazwy:
IV over 3 hours twice daily
Inne nazwy:
IV over 15 minutes
Inne nazwy:
oral twice daily
Inne nazwy:
IV over 1 hour
Inne nazwy:
rescue IV over 24 hours
Inne nazwy:
oral
Inne nazwy:
intramuscularly (IM)
Inne nazwy:
intramuscularly (IM)
Inne nazwy:
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation.
Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
|
|
Eksperymentalny: Testicular Relapse Patients (Combination chemotherapy)
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
|
podane IV
Inne nazwy:
given subcutaneously (SC)
Inne nazwy:
IV over 15-30 minutes
Inne nazwy:
IV over 3 hours twice daily
Inne nazwy:
IV over 15 minutes
Inne nazwy:
oral twice daily
Inne nazwy:
IV over 1 hour
Inne nazwy:
rescue IV over 24 hours
Inne nazwy:
oral
Inne nazwy:
intramuscularly (IM)
Inne nazwy:
intramuscularly (IM)
Inne nazwy:
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation.
Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Event-free Survival
Ramy czasowe: 3 years
|
Monitoring of efficacy results will be performed in comparison with historical results.
|
3 years
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
- Krzesło do nauki: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 listopada 2004
Zakończenie podstawowe (Rzeczywisty)
1 września 2013
Daty rejestracji na studia
Pierwszy przesłany
9 listopada 2004
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 listopada 2004
Pierwszy wysłany (Oszacować)
9 listopada 2004
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
21 marca 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 lutego 2017
Ostatnia weryfikacja
1 lutego 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Nowotwory
- Zaburzenia limfoproliferacyjne
- Choroby limfatyczne
- Zaburzenia immunoproliferacyjne
- Białaczka
- Prekursorowa komórkowa białaczka limfoblastyczna-chłoniak
- Białaczka, układ limfatyczny
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwinfekcyjne
- Agenci autonomiczni
- Agenty obwodowego układu nerwowego
- Środki przeciwwirusowe
- Inhibitory syntezy kwasów nukleinowych
- Inhibitory enzymów
- Środki przeciwzapalne
- Środki przeciwreumatyczne
- Antymetabolity, przeciwnowotworowe
- Antymetabolity
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Modulatory tubuliny
- Środki antymitotyczne
- Modulatory mitozy
- Leki przeciwwymiotne
- Środki żołądkowo-jelitowe
- Glikokortykosteroidy
- Hormony
- Hormony, substytuty hormonów i antagoniści hormonów
- Środki przeciwnowotworowe, hormonalne
- Środki ochronne
- Środki przeciwnowotworowe, alkilujące
- Środki alkilujące
- Agoniści mieloablacyjni
- Środki przeciwnowotworowe, Fitogenne
- Inhibitory topoizomerazy II
- Inhibitory topoizomerazy
- Środki dermatologiczne
- Mikroelementy
- Adiuwanty, immunologiczne
- Antybiotyki, Przeciwnowotworowe
- Witaminy
- Środki kontroli reprodukcji
- Odtrutki
- Kompleks witamin B
- Środki poronne, niesteroidowe
- Środki poronne
- Antagoniści kwasu foliowego
- Deksametazon
- Cyklofosfamid
- Etopozyd
- Leukoworyna
- Lewoleukoworyna
- Lenograstym
- Cytarabina
- Metotreksat
- Winkrystyna
- Daunorubicyna
- Asparaginaza
- Merkaptopuryna
- Hydrokortyzon
- Hydrokortyzon 17-maślan 21-propionian
- Octan hydrokortyzonu
- Hemibursztynian hydrokortyzonu
- Pegaspargaza
Inne numery identyfikacyjne badania
- AALL02P2
- COG-AALL02P2 (Inny identyfikator: Children's Oncology Group)
- NCI-2011-01623 (Inny identyfikator: NCI Trial Identifier)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .