Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
14 de fevereiro de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
- Medicamento: hidrocortisona terapêutica
- Medicamento: sulfato de vincristina
- Biológico: filgrastim
- Medicamento: cyclophosphamide
- Medicamento: cytarabine
- Medicamento: daunorubicin hydrochloride
- Medicamento: dexamethasone
- Medicamento: etoposide
- Medicamento: leucovorin calcium
- Medicamento: mercaptopurine
- Medicamento: methotrexate
- Medicamento: pegaspargase
- Radiação: radiation therapy
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
168
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Western Australia
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Perth, Western Australia, Austrália, 6001
- Princess Margaret Hospital for Children
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Quebec, Canadá, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Edmonton, Alberta, Canadá, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canadá, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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Ottawa, Ontario, Canadá, K1H 8L1
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, Canadá, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016-7710
- Phoenix Children's Hospital
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Tucson, Arizona, Estados Unidos, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Estados Unidos, 90027
- Southern California Permanente Medical Group
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Duarte, California, Estados Unidos, 91010-3000
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Estados Unidos, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Estados Unidos, 90027
- Childrens Hospital Los Angeles
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Madera, California, Estados Unidos, 93638-8762
- Children's Hospital Central California
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Oakland, California, Estados Unidos, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Estados Unidos, 95798
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Estados Unidos, 95816
- Sutter Cancer Center
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Sacramento, California, Estados Unidos, 95825
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Estados Unidos, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Estados Unidos, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Estados Unidos, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Estados Unidos, 32610-0232
- University of Florida Shands Cancer Center
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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Miami, Florida, Estados Unidos, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
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Miami, Florida, Estados Unidos, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Estados Unidos, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Estados Unidos, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Estados Unidos, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
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Tampa, Florida, Estados Unidos, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Estados Unidos, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 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, Estados Unidos, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Estados Unidos, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60612-7243
- University of Illinois Cancer Center
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Maywood, Illinois, Estados Unidos, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Oak Lawn, Illinois, Estados Unidos, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Estados Unidos, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Estados Unidos, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Estados Unidos, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Estados Unidos, 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, Estados Unidos, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Estados Unidos, 40232
- Kosair Children's Hospital
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Maine
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Bangor, Maine, Estados Unidos, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Estados Unidos, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Estados Unidos, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Estados Unidos, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Estados Unidos, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Estados Unidos, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, Estados Unidos, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Estados Unidos, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Estados Unidos, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Estados Unidos, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, Estados Unidos, 11501
- Winthrop University Hospital
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New Hyde Park, New York, Estados Unidos, 11040
- Schneider Children's Hospital
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New York, New York, Estados Unidos, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Estados Unidos, 11794-9446
- Stony Brook University Cancer Center
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Estados Unidos, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Estados Unidos, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Estados Unidos, 44308-1062
- Akron Children's Hospital
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Estados Unidos, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Estados Unidos, 45404-1815
- Dayton Children's - Dayton
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Toledo, Ohio, Estados Unidos, 43614
- Medical University of Ohio Cancer Center
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Youngstown, Ohio, Estados Unidos, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Estados Unidos, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Estados Unidos, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Estados Unidos, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Estados Unidos, 37901
- East Tennessee Children's Hospital
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Nashville, Tennessee, Estados Unidos, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, Estados Unidos, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Estados Unidos, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Estados Unidos, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Estados Unidos, 77030-2399
- Baylor University Medical Center - Houston
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San Antonio, Texas, Estados Unidos, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042-3300
- INOVA Fairfax Hospital
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Roanoke, Virginia, Estados Unidos, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Spokane, Washington, Estados Unidos, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University Health Sciences Center - Charleston
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Morgantown, West Virginia, Estados Unidos, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Center for Cancer and Blood
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Auckland, Nova Zelândia, 1
- Starship Children's Health
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Christchurch, Nova Zelândia, 8140
- Christchurch Hospital
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Bern, Suíça, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Suíça, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Suíça, 1011
- Swiss Pediatric Oncology Group Lausanne
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
1 ano a 29 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
dado IV
Outros nomes:
given subcutaneously (SC)
Outros nomes:
IV over 15-30 minutes
Outros nomes:
IV over 3 hours twice daily
Outros nomes:
IV over 15 minutes
Outros nomes:
oral twice daily
Outros nomes:
IV over 1 hour
Outros nomes:
rescue IV over 24 hours
Outros nomes:
oral
Outros nomes:
intramuscularly (IM)
Outros nomes:
intramuscularly (IM)
Outros nomes:
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.
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Experimental: 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.
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dado IV
Outros nomes:
given subcutaneously (SC)
Outros nomes:
IV over 15-30 minutes
Outros nomes:
IV over 3 hours twice daily
Outros nomes:
IV over 15 minutes
Outros nomes:
oral twice daily
Outros nomes:
IV over 1 hour
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rescue IV over 24 hours
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oral
Outros nomes:
intramuscularly (IM)
Outros nomes:
intramuscularly (IM)
Outros nomes:
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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Event-free Survival
Prazo: 3 years
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Monitoring of efficacy results will be performed in comparison with historical results.
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3 years
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
- Cadeira de estudo: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2004
Conclusão Primária (Real)
1 de setembro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
9 de novembro de 2004
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de novembro de 2004
Primeira postagem (Estimativa)
9 de novembro de 2004
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de março de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de fevereiro de 2017
Última verificação
1 de fevereiro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Leucemia
- Leucemia-Linfoma Linfoblástico de Células Precursoras
- Leucemia Linfóide
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Antivirais
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Antieméticos
- Agentes gastrointestinais
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Agentes de proteção
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Agonistas Mieloablativos
- Agentes Antineoplásicos Fitogênicos
- Inibidores da Topoisomerase II
- Inibidores da Topoisomerase
- Agentes dermatológicos
- Micronutrientes
- Adjuvantes Imunológicos
- Antibióticos, Antineoplásicos
- Vitaminas
- Agentes de Controle Reprodutivo
- Antídotos
- Complexo de Vitamina B
- Agentes abortivos, não esteróides
- Agentes abortivos
- Antagonistas do ácido fólico
- Dexametasona
- Ciclofosfamida
- Etoposídeo
- Leucovorina
- Levoleucovorina
- Lenograstim
- Citarabina
- Metotrexato
- Vincristina
- Daunorrubicina
- Asparaginase
- Mercaptopurina
- Hidrocortisona
- Hidrocortisona 17-butirato 21-propionato
- Acetato de hidrocortisona
- Hemisuccinato de hidrocortisona
- Pegaspargase
Outros números de identificação do estudo
- AALL02P2
- COG-AALL02P2 (Outro identificador: Children's Oncology Group)
- NCI-2011-01623 (Outro identificador: NCI Trial Identifier)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .