Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
14. února 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
OBJECTIVES:
Primary
- Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse.
- Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse.
- Determine the toxicity of these regimens in these patients.
Secondary
- Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens.
- Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens.
- Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients.
- Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients.
OUTLINE: This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).
- Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22.
NOTE: *The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose is reached, all subsequent doses of daunorubicin are omitted.
NOTE: **Patients with isolated testicular relapse receive ITT on day 1 only.
In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy.
Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36.
- Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover.
Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.
- Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT* on days 15, 36, 57, and 78.
NOTE: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.
- Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over 15 minutes on days 1, 8, and 15.
- Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover.
NOTE: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.
- Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM on days 1 and 15.
Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions.
- Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses.
Maintenance therapy for isolated testicular relapse:
- (Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.
- (Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses.
Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients.
All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment.
Patients are followed for survival.
Typ studie
Intervenční
Zápis (Aktuální)
168
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Western Australia
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Perth, Western Australia, Austrálie, 6001
- Princess Margaret Hospital for Children
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Quebec, Kanada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Kanada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Kanada, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, Kanada, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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-
-
-
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Auckland, Nový Zéland, 1
- Starship Children's Health
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Christchurch, Nový Zéland, 8140
- Christchurch Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Spojené státy, 85016-7710
- Phoenix Children's Hospital
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Tucson, Arizona, Spojené státy, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Spojené státy, 90027
- Southern California Permanente Medical Group
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Duarte, California, Spojené státy, 91010-3000
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Spojené státy, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Spojené státy, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Spojené státy, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Spojené státy, 90027
- Childrens Hospital Los Angeles
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Madera, California, Spojené státy, 93638-8762
- Children's Hospital Central California
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Oakland, California, Spojené státy, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Spojené státy, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Spojené státy, 95798
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Spojené státy, 95816
- Sutter Cancer Center
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Sacramento, California, Spojené státy, 95825
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Spojené státy, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Spojené státy, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Spojené státy, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Spojené státy, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Spojené státy, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Spojené státy, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Spojené státy, 32610-0232
- University of Florida Shands Cancer Center
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Hollywood, Florida, Spojené státy, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Spojené státy, 32207
- Nemours Children's Clinic
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Miami, Florida, Spojené státy, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Spojené státy, 33155
- Miami Children's Hospital
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Miami, Florida, Spojené státy, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Spojené státy, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Spojené státy, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Spojené státy, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Spojené státy, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Spojené státy, 33701
- All Children's Hospital
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Tampa, Florida, Spojené státy, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Spojené státy, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Spojené státy, 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, Spojené státy, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Spojené státy, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Spojené státy, 60612-7243
- University of Illinois Cancer Center
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Maywood, Illinois, Spojené státy, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Oak Lawn, Illinois, Spojené státy, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, Spojené státy, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Spojené státy, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Spojené státy, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Spojené státy, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Spojené státy, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Spojené státy, 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, Spojené státy, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Spojené státy, 40232
- Kosair Children's Hospital
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Maine
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Bangor, Maine, Spojené státy, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Spojené státy, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Spojené státy, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Spojené státy, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Spojené státy, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Spojené státy, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Spojené státy, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Spojené státy, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Spojené státy, 64108
- Children's Mercy Hospital
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Nevada
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Las Vegas, Nevada, Spojené státy, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Spojené státy, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Spojené státy, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Spojené státy, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, Spojené státy, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Spojené státy, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Spojené státy, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Spojené státy, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Spojené státy, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Spojené státy, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, Spojené státy, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, Spojené státy, 11501
- Winthrop University Hospital
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New Hyde Park, New York, Spojené státy, 11040
- Schneider Children's Hospital
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New York, New York, Spojené státy, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Spojené státy, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Spojené státy, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Spojené státy, 11794-9446
- Stony Brook University Cancer Center
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Syracuse, New York, Spojené státy, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Spojené státy, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Spojené státy, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Spojené státy, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Spojené státy, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Spojené státy, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Spojené státy, 44308-1062
- Akron Children's Hospital
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Spojené státy, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Spojené státy, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Spojené státy, 45404-1815
- Dayton Children's - Dayton
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Toledo, Ohio, Spojené státy, 43614
- Medical University of Ohio Cancer Center
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Youngstown, Ohio, Spojené státy, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Spojené státy, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Spojené státy, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Bethlehem, Pennsylvania, Spojené státy, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Spojené státy, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Spojené státy, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Spojené státy, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Spojené státy, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Greenville, South Carolina, Spojené státy, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Spojené státy, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Spojené státy, 37901
- East Tennessee Children's Hospital
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Nashville, Tennessee, Spojené státy, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Spojené státy, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, Spojené státy, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Spojené státy, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Spojené státy, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, Spojené státy, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Spojené státy, 77030-2399
- Baylor University Medical Center - Houston
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San Antonio, Texas, Spojené státy, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Spojené státy, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Spojené státy, 84113-1100
- Primary Children's Medical Center
-
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Vermont
-
Burlington, Vermont, Spojené státy, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
-
Falls Church, Virginia, Spojené státy, 22042-3300
- INOVA Fairfax Hospital
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Roanoke, Virginia, Spojené státy, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Spokane, Washington, Spojené státy, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, Spojené státy, 25302
- West Virginia University Health Sciences Center - Charleston
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Morgantown, West Virginia, Spojené státy, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Spojené státy, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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La Crosse, Wisconsin, Spojené státy, 54601
- Gundersen Lutheran Center for Cancer and Blood
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Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Spojené státy, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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-
-
-
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Bern, Švýcarsko, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Švýcarsko, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Švýcarsko, 1011
- Swiss Pediatric Oncology Group Lausanne
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
1 rok až 29 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
daný IV
Ostatní jména:
given subcutaneously (SC)
Ostatní jména:
IV over 15-30 minutes
Ostatní jména:
IV over 3 hours twice daily
Ostatní jména:
IV over 15 minutes
Ostatní jména:
oral twice daily
Ostatní jména:
IV over 1 hour
Ostatní jména:
rescue IV over 24 hours
Ostatní jména:
oral
Ostatní jména:
intramuscularly (IM)
Ostatní jména:
intramuscularly (IM)
Ostatní jména:
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.
|
|
Experimentální: 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.
|
daný IV
Ostatní jména:
given subcutaneously (SC)
Ostatní jména:
IV over 15-30 minutes
Ostatní jména:
IV over 3 hours twice daily
Ostatní jména:
IV over 15 minutes
Ostatní jména:
oral twice daily
Ostatní jména:
IV over 1 hour
Ostatní jména:
rescue IV over 24 hours
Ostatní jména:
oral
Ostatní jména:
intramuscularly (IM)
Ostatní jména:
intramuscularly (IM)
Ostatní jména:
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation.
Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Event-free Survival
Časové okno: 3 years
|
Monitoring of efficacy results will be performed in comparison with historical results.
|
3 years
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
- Studijní židle: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2004
Primární dokončení (Aktuální)
1. září 2013
Termíny zápisu do studia
První předloženo
9. listopadu 2004
První předloženo, které splnilo kritéria kontroly kvality
8. listopadu 2004
První zveřejněno (Odhad)
9. listopadu 2004
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
21. března 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. února 2017
Naposledy ověřeno
1. února 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Novotvary
- Lymfoproliferativní poruchy
- Lymfatická onemocnění
- Imunoproliferativní poruchy
- Leukémie
- Lymfoblastická leukémie-lymfom prekurzorových buněk
- Leukémie, lymfoidní
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antiinfekční látky
- Autonomní agenti
- Agenti periferního nervového systému
- Antivirová činidla
- Inhibitory syntézy nukleových kyselin
- Inhibitory enzymů
- Protizánětlivé látky
- Antirevmatika
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Antiemetika
- Gastrointestinální látky
- Glukokortikoidy
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Antineoplastická činidla, Hormonální
- Ochranné prostředky
- Antineoplastická činidla, Alkylační
- Alkylační činidla
- Myeloablativní agonisté
- Antineoplastické látky, fytogenní
- Inhibitory topoizomerázy II
- Inhibitory topoizomerázy
- Dermatologická činidla
- Mikroživiny
- Adjuvans, Imunologická
- Antibiotika, antineoplastika
- Vitamíny
- Činidla pro kontrolu reprodukce
- Protijedy
- Vitamín B komplex
- Abortivní látky, nesteroidní
- Abortivní látky
- Antagonisté kyseliny listové
- Dexamethason
- Cyklofosfamid
- Etoposid
- Leukovorin
- Levoleukovorin
- Lenograstim
- Cytarabin
- Methotrexát
- Vinkristine
- Daunorubicin
- Asparagináza
- Merkaptopurin
- Hydrokortison
- Hydrokortison 17-butyrát 21-propionát
- Hydrokortison acetát
- Hydrokortison hemisukcinát
- Pegaspargase
Další identifikační čísla studie
- AALL02P2
- COG-AALL02P2 (Jiný identifikátor: Children's Oncology Group)
- NCI-2011-01623 (Jiný identifikátor: NCI Trial Identifier)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .