Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
14. februar 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Medicin: terapeutisk hydrocortison
- Medicin: vincristinsulfat
- Biologisk: filgrastim
- Medicin: cyclophosphamide
- Medicin: cytarabine
- Medicin: daunorubicin hydrochloride
- Medicin: dexamethasone
- Medicin: etoposide
- Medicin: leucovorin calcium
- Medicin: mercaptopurine
- Medicin: methotrexate
- Medicin: pegaspargase
- Stråling: radiation therapy
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
168
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Western Australia
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Perth, Western Australia, Australien, 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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-
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016-7710
- Phoenix Children's Hospital
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Tucson, Arizona, Forenede Stater, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Forenede Stater, 90027
- Southern California Permanente Medical Group
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Forenede Stater, 90027
- Childrens Hospital Los Angeles
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Madera, California, Forenede Stater, 93638-8762
- Children's Hospital Central California
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Oakland, California, Forenede Stater, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Forenede Stater, 95798
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Forenede Stater, 95816
- Sutter Cancer Center
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Sacramento, California, Forenede Stater, 95825
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Forenede Stater, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803
- Alfred I. DuPont Hospital for Children
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-
District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Forenede Stater, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Forenede Stater, 32610-0232
- University of Florida Shands Cancer Center
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Forenede Stater, 33155
- Miami Children's Hospital
-
Miami, Florida, Forenede Stater, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Forenede Stater, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Forenede Stater, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Forenede Stater, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Forenede Stater, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Forenede Stater, 33701
- All Children's Hospital
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Tampa, Florida, Forenede Stater, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Forenede Stater, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 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, Forenede Stater, 96813
- Cancer Research Center of Hawaii
-
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Idaho
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Boise, Idaho, Forenede Stater, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
-
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Illinois
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Chicago, Illinois, Forenede Stater, 60612-7243
- University of Illinois Cancer Center
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Oak Lawn, Illinois, Forenede Stater, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, Forenede Stater, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Forenede Stater, 62794-9677
- Simmons Cooper Cancer Institute
-
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Forenede Stater, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Forenede Stater, 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, Forenede Stater, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Forenede Stater, 40232
- Kosair Children's Hospital
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Maine
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Bangor, Maine, Forenede Stater, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forenede Stater, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Forenede Stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Forenede Stater, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Forenede Stater, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forenede Stater, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Forenede Stater, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Forenede Stater, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, Forenede Stater, 11501
- Winthrop University Hospital
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New Hyde Park, New York, Forenede Stater, 11040
- Schneider Children's Hospital
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New York, New York, Forenede Stater, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Forenede Stater, 11794-9446
- Stony Brook University Cancer Center
-
Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Forenede Stater, 10595
- New York Medical College
-
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Forenede Stater, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Forenede Stater, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Forenede Stater, 44308-1062
- Akron Children's Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forenede Stater, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Forenede Stater, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Forenede Stater, 45404-1815
- Dayton Children's - Dayton
-
Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
-
Youngstown, Ohio, Forenede Stater, 44501
- Tod Children's Hospital
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-
Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Cancer Institute
-
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Oregon
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Portland, Oregon, Forenede Stater, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Forenede Stater, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Forenede Stater, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh of UPMC
-
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital Comprehensive Cancer Center
-
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Greenville Hospital Cancer Center
-
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Forenede Stater, 37901
- East Tennessee Children's Hospital
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Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Forenede Stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Forenede Stater, 77030-2399
- Baylor University Medical Center - Houston
-
San Antonio, Texas, Forenede Stater, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Forenede Stater, 78207
- University of Texas Health Science Center at San Antonio
-
-
Utah
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Salt Lake City, Utah, Forenede Stater, 84113-1100
- Primary Children's Medical Center
-
-
Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
-
Virginia
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Falls Church, Virginia, Forenede Stater, 22042-3300
- INOVA Fairfax Hospital
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Roanoke, Virginia, Forenede Stater, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Spokane, Washington, Forenede Stater, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25302
- West Virginia University Health Sciences Center - Charleston
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Morgantown, West Virginia, Forenede Stater, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Center for Cancer and Blood
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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-
-
-
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Auckland, New Zealand, 1
- Starship Children's Health
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Christchurch, New Zealand, 8140
- Christchurch Hospital
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-
-
-
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Bern, Schweiz, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Schweiz, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Schweiz, 1011
- Swiss Pediatric Oncology Group Lausanne
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 29 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
givet IV
Andre navne:
given subcutaneously (SC)
Andre navne:
IV over 15-30 minutes
Andre navne:
IV over 3 hours twice daily
Andre navne:
IV over 15 minutes
Andre navne:
oral twice daily
Andre navne:
IV over 1 hour
Andre navne:
rescue IV over 24 hours
Andre navne:
oral
Andre navne:
intramuscularly (IM)
Andre navne:
intramuscularly (IM)
Andre navne:
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.
|
|
Eksperimentel: 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.
|
givet IV
Andre navne:
given subcutaneously (SC)
Andre navne:
IV over 15-30 minutes
Andre navne:
IV over 3 hours twice daily
Andre navne:
IV over 15 minutes
Andre navne:
oral twice daily
Andre navne:
IV over 1 hour
Andre navne:
rescue IV over 24 hours
Andre navne:
oral
Andre navne:
intramuscularly (IM)
Andre navne:
intramuscularly (IM)
Andre navne:
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Event-free Survival
Tidsramme: 3 years
|
Monitoring of efficacy results will be performed in comparison with historical results.
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
- Studiestol: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2004
Primær færdiggørelse (Faktiske)
1. september 2013
Datoer for studieregistrering
Først indsendt
9. november 2004
Først indsendt, der opfyldte QC-kriterier
8. november 2004
Først opslået (Skøn)
9. november 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Leukæmi
- Precursorcelle lymfoblastisk leukæmi-lymfom
- Leukæmi, lymfoid
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Autonome agenter
- Agenter fra det perifere nervesystem
- Antivirale midler
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Beskyttelsesagenter
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Dermatologiske midler
- Mikronæringsstoffer
- Adjuvanser, immunologiske
- Antibiotika, antineoplastisk
- Vitaminer
- Reproduktive kontrolmidler
- Modgift
- Vitamin B kompleks
- Abortfremkaldende midler, ikke-steroide
- Aborterende midler
- Folinsyreantagonister
- Dexamethason
- Cyclofosfamid
- Etoposid
- Leucovorin
- Levoleucovorin
- Lenograstim
- Cytarabin
- Methotrexat
- Vincristine
- Daunorubicin
- Asparaginase
- Mercaptopurin
- Hydrocortison
- Hydrocortison 17-butyrat 21-propionat
- Hydrocortisonacetat
- Hydrocortison hemisuccinat
- Pegaspargase
Andre undersøgelses-id-numre
- AALL02P2
- COG-AALL02P2 (Anden identifikator: Children's Oncology Group)
- NCI-2011-01623 (Anden identifikator: NCI Trial Identifier)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .