Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
14 febbraio 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
- Droga: idrocortisone terapeutico
- Droga: vincristina solfato
- Biologico: filgrastim
- Droga: cyclophosphamide
- Droga: cytarabine
- Droga: daunorubicin hydrochloride
- Droga: dexamethasone
- Droga: etoposide
- Droga: leucovorin calcium
- Droga: mercaptopurine
- Droga: methotrexate
- Droga: pegaspargase
- Radiazione: radiation therapy
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
168
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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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, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Auckland, Nuova Zelanda, 1
- Starship Children's Health
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Christchurch, Nuova Zelanda, 8140
- Christchurch Hospital
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Stati Uniti, 85016-7710
- Phoenix Children's Hospital
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Tucson, Arizona, Stati Uniti, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Stati Uniti, 90027
- Southern California Permanente Medical Group
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Duarte, California, Stati Uniti, 91010-3000
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Stati Uniti, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Stati Uniti, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Stati Uniti, 90027
- Childrens Hospital Los Angeles
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Madera, California, Stati Uniti, 93638-8762
- Children's Hospital Central California
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Oakland, California, Stati Uniti, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Stati Uniti, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Stati Uniti, 95798
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Stati Uniti, 95816
- Sutter Cancer Center
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Sacramento, California, Stati Uniti, 95825
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Stati Uniti, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Stati Uniti, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Stati Uniti, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Stati Uniti, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Stati Uniti, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Stati Uniti, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Stati Uniti, 32610-0232
- University of Florida Shands Cancer Center
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Hollywood, Florida, Stati Uniti, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Stati Uniti, 32207
- Nemours Children's Clinic
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Miami, Florida, Stati Uniti, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Stati Uniti, 33155
- Miami Children's Hospital
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Miami, Florida, Stati Uniti, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Stati Uniti, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Stati Uniti, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Stati Uniti, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Stati Uniti, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Stati Uniti, 33701
- All Children's Hospital
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Tampa, Florida, Stati Uniti, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Stati Uniti, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 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, Stati Uniti, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Stati Uniti, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Stati Uniti, 60612-7243
- University of Illinois Cancer Center
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Maywood, Illinois, Stati Uniti, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Oak Lawn, Illinois, Stati Uniti, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, Stati Uniti, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Stati Uniti, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Stati Uniti, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Stati Uniti, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Stati Uniti, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Stati Uniti, 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, Stati Uniti, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Stati Uniti, 40232
- Kosair Children's Hospital
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Maine
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Bangor, Maine, Stati Uniti, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Stati Uniti, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Stati Uniti, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Stati Uniti, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Stati Uniti, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Stati Uniti, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Stati Uniti, 64108
- Children's Mercy Hospital
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Stati Uniti, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Stati Uniti, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, Stati Uniti, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Stati Uniti, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Stati Uniti, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Stati Uniti, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Stati Uniti, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Stati Uniti, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, Stati Uniti, 11501
- Winthrop University Hospital
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New Hyde Park, New York, Stati Uniti, 11040
- Schneider Children's Hospital
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New York, New York, Stati Uniti, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Stati Uniti, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Stati Uniti, 11794-9446
- Stony Brook University Cancer Center
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Stati Uniti, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Stati Uniti, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Stati Uniti, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Stati Uniti, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Stati Uniti, 44308-1062
- Akron Children's Hospital
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Stati Uniti, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Stati Uniti, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Stati Uniti, 45404-1815
- Dayton Children's - Dayton
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Toledo, Ohio, Stati Uniti, 43614
- Medical University of Ohio Cancer Center
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Youngstown, Ohio, Stati Uniti, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Stati Uniti, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Stati Uniti, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Bethlehem, Pennsylvania, Stati Uniti, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Stati Uniti, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Stati Uniti, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Stati Uniti, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Stati Uniti, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Greenville, South Carolina, Stati Uniti, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Stati Uniti, 37901
- East Tennessee Children's Hospital
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Nashville, Tennessee, Stati Uniti, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Stati Uniti, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, Stati Uniti, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Stati Uniti, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Stati Uniti, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Stati Uniti, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Stati Uniti, 77030-2399
- Baylor University Medical Center - Houston
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San Antonio, Texas, Stati Uniti, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Stati Uniti, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Stati Uniti, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Falls Church, Virginia, Stati Uniti, 22042-3300
- INOVA Fairfax Hospital
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Roanoke, Virginia, Stati Uniti, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Spokane, Washington, Stati Uniti, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, Stati Uniti, 25302
- West Virginia University Health Sciences Center - Charleston
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Morgantown, West Virginia, Stati Uniti, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Stati Uniti, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Lutheran Center for Cancer and Blood
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Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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-
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Bern, Svizzera, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Svizzera, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Svizzera, 1011
- Swiss Pediatric Oncology Group Lausanne
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 anno a 29 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
dato IV
Altri nomi:
given subcutaneously (SC)
Altri nomi:
IV over 15-30 minutes
Altri nomi:
IV over 3 hours twice daily
Altri nomi:
IV over 15 minutes
Altri nomi:
oral twice daily
Altri nomi:
IV over 1 hour
Altri nomi:
rescue IV over 24 hours
Altri nomi:
oral
Altri nomi:
intramuscularly (IM)
Altri nomi:
intramuscularly (IM)
Altri nomi:
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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Sperimentale: 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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dato IV
Altri nomi:
given subcutaneously (SC)
Altri nomi:
IV over 15-30 minutes
Altri nomi:
IV over 3 hours twice daily
Altri nomi:
IV over 15 minutes
Altri nomi:
oral twice daily
Altri nomi:
IV over 1 hour
Altri nomi:
rescue IV over 24 hours
Altri nomi:
oral
Altri nomi:
intramuscularly (IM)
Altri nomi:
intramuscularly (IM)
Altri nomi:
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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Event-free Survival
Lasso di tempo: 3 years
|
Monitoring of efficacy results will be performed in comparison with historical results.
|
3 years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
- Cattedra di studio: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2004
Completamento primario (Effettivo)
1 settembre 2013
Date di iscrizione allo studio
Primo inviato
9 novembre 2004
Primo inviato che soddisfa i criteri di controllo qualità
8 novembre 2004
Primo Inserito (Stima)
9 novembre 2004
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 marzo 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 febbraio 2017
Ultimo verificato
1 febbraio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Leucemia
- Leucemia-linfoma linfoblastico a cellule precursori
- Leucemia, linfoide
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antivirali
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti antireumatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Agenti protettivi
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Agenti dermatologici
- Micronutrienti
- Adiuvanti, immunologici
- Antibiotici, Antineoplastici
- Vitamine
- Agenti di controllo riproduttivo
- Antidoti
- Complesso di vitamina B
- Agenti abortivi, non steroidei
- Agenti abortivi
- Antagonisti dell'acido folico
- Desametasone
- Ciclofosfamide
- Etoposide
- Leucovorin
- Levoleucovorin
- Lenograstim
- Citarabina
- Metotrexato
- Vincristina
- Daunorubicina
- Asparaginasi
- Mercaptopurina
- Idrocortisone
- Idrocortisone 17-butirrato 21-propionato
- Acetato di idrocortisone
- Idrocortisone emisuccinato
- Pegaspargasi
Altri numeri di identificazione dello studio
- AALL02P2
- COG-AALL02P2 (Altro identificatore: Children's Oncology Group)
- NCI-2011-01623 (Altro identificatore: NCI Trial Identifier)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .