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Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

14 februari 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

168

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • UAB Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85016-7710
        • Phoenix Children's Hospital
      • Tucson, Arizona, Förenta staterna, 85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, Förenta staterna, 90027
        • Southern California Permanente Medical Group
      • Duarte, California, Förenta staterna, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, Förenta staterna, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Förenta staterna, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, Förenta staterna, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, Förenta staterna, 90027
        • Childrens Hospital Los Angeles
      • Madera, California, Förenta staterna, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Förenta staterna, 94609
        • Children's Hospital and Research Center Oakland
      • Orange, California, Förenta staterna, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Förenta staterna, 95798
        • Lucile Packard Children's Hospital at Stanford University Medical Center
      • Sacramento, California, Förenta staterna, 95816
        • Sutter Cancer center
      • Sacramento, California, Förenta staterna, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Francisco, California, Förenta staterna, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Children's Hospital Center for Cancer and Blood Disorders
      • Denver, Colorado, Förenta staterna, 80218
        • Presbyterian - St. Luke's Medical Center
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06106
        • Connecticut Children's Medical Center
    • Delaware
      • Wilmington, Delaware, Förenta staterna, 19803
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale, Florida, Förenta staterna, 33316
        • Broward General Medical Center Cancer Center
      • Fort Myers, Florida, Förenta staterna, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, Förenta staterna, 32610-0232
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, Förenta staterna, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, Förenta staterna, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Förenta staterna, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
      • Miami, Florida, Förenta staterna, 33155
        • Miami Children's Hospital
      • Miami, Florida, Förenta staterna, 33176
        • Baptist-South Miami Regional Cancer Program
      • Orlando, Florida, Förenta staterna, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Orlando, Florida, Förenta staterna, 32806
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, Förenta staterna, 32806
        • M.D. Anderson Cancer Center at Orlando
      • Pensacola, Florida, Förenta staterna, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Saint Petersburg, Florida, Förenta staterna, 33701
        • All Children's Hospital
      • Tampa, Florida, Förenta staterna, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, Förenta staterna, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
    • Hawaii
      • Honolulu, Hawaii, Förenta staterna, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, Förenta staterna, 83712-6297
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60612-7243
        • University of Illinois Cancer Center
      • Maywood, Illinois, Förenta staterna, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Oak Lawn, Illinois, Förenta staterna, 60453
        • Keyser Family Cancer Center at Advocate Hope Children's Hospital
      • Park Ridge, Illinois, Förenta staterna, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Springfield, Illinois, Förenta staterna, 62794-9677
        • Simmons Cooper Cancer Institute
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Förenta staterna, 46260
        • St. Vincent Indianapolis Hospital
    • Iowa
      • Des Moines, Iowa, Förenta staterna, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, Förenta staterna, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Kansas City, Kansas, Förenta staterna, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
      • Louisville, Kentucky, Förenta staterna, 40232
        • Kosair Children's Hospital
    • Maine
      • Bangor, Maine, Förenta staterna, 04401
        • CancerCare of Maine at Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02111
        • Floating Hospital for Children at Tufts - New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109-0286
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Detroit, Michigan, Förenta staterna, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, Förenta staterna, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Förenta staterna, 49503-2560
        • Butterworth Hospital at Spectrum Health
      • Grosse Pointe Woods, Michigan, Förenta staterna, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, Förenta staterna, 49007-5381
        • CCOP - Kalamazoo
      • Lansing, Michigan, Förenta staterna, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, Förenta staterna, 39216-4505
        • University of Mississippi Cancer Clinic
    • Missouri
      • Columbia, Missouri, Förenta staterna, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Förenta staterna, 64108
        • Children's Mercy Hospital
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89109-2306
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • Hackensack University Medical Center Cancer Center
      • Morristown, New Jersey, Förenta staterna, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, Förenta staterna, 08901
        • Saint Peter's University Hospital
      • New Brunswick, New Jersey, Förenta staterna, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, Förenta staterna, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Förenta staterna, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87131-5636
        • University of New Mexico Cancer Center
    • New York
      • Bronx, New York, Förenta staterna, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, Förenta staterna, 11201-5493
        • Brooklyn Hospital Center
      • Brooklyn, New York, Förenta staterna, 11219
        • Maimonides Cancer Center at Maimonides Medical Center
      • Buffalo, New York, Förenta staterna, 14263-0001
        • Roswell Park Cancer Institute
      • Mineola, New York, Förenta staterna, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, Förenta staterna, 11040
        • Schneider Children's Hospital
      • New York, New York, Förenta staterna, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, Förenta staterna, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Rochester, New York, Förenta staterna, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, Förenta staterna, 11794-9446
        • Stony Brook University Cancer Center
      • Syracuse, New York, Förenta staterna, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, Förenta staterna, 10595
        • New York Medical College
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Förenta staterna, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Förenta staterna, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • North Dakota
      • Fargo, North Dakota, Förenta staterna, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Akron, Ohio, Förenta staterna, 44308-1062
        • Akron Children's Hospital
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Förenta staterna, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Columbus, Ohio, Förenta staterna, 43205-2696
        • Nationwide Children's Hospital
      • Dayton, Ohio, Förenta staterna, 45404-1815
        • Dayton Children's - Dayton
      • Toledo, Ohio, Förenta staterna, 43614
        • Medical University of Ohio Cancer Center
      • Youngstown, Ohio, Förenta staterna, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239-3098
        • Knight Cancer Institute At Oregon Health and Science University
      • Portland, Oregon, Förenta staterna, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Pennsylvania
      • Bethlehem, Pennsylvania, Förenta staterna, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, Förenta staterna, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hershey, Pennsylvania, Förenta staterna, 17033-0850
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Förenta staterna, 19134-1095
        • St. Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, Förenta staterna, 19104-9786
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • Children's Hospital of Pittsburgh of UPMC
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Greenville, South Carolina, Förenta staterna, 29605
        • Greenville Hospital Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, Förenta staterna, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Chattanooga, Tennessee, Förenta staterna, 37403
        • T.C. Thompson Children's Hospital
      • Knoxville, Tennessee, Förenta staterna, 37901
        • East Tennessee Children's Hospital
      • Nashville, Tennessee, Förenta staterna, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Amarillo, Texas, Förenta staterna, 79106
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
      • Corpus Christi, Texas, Förenta staterna, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, Förenta staterna, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, Förenta staterna, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, Förenta staterna, 76104
        • Cook Children's Medical Center - Fort Worth
      • Houston, Texas, Förenta staterna, 77030-2399
        • Baylor University Medical Center - Houston
      • San Antonio, Texas, Förenta staterna, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, Förenta staterna, 78207
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, Förenta staterna, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Falls Church, Virginia, Förenta staterna, 22042-3300
        • Inova Fairfax Hospital
      • Roanoke, Virginia, Förenta staterna, 24014
        • Carilion Medical Center for Children at Roanoke Community Hospital
    • Washington
      • Spokane, Washington, Förenta staterna, 99220-2555
        • Providence Cancer Center at Sacred Heart Medical Center
    • West Virginia
      • Charleston, West Virginia, Förenta staterna, 25302
        • West Virginia University Health Sciences Center - Charleston
      • Morgantown, West Virginia, Förenta staterna, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, Förenta staterna, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • La Crosse, Wisconsin, Förenta staterna, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Marshfield, Wisconsin, Förenta staterna, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Midwest Children's Cancer Center at Children's Hospital of Wisconsin
  • Kanada
      • Quebec, Kanada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3J 3G9
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Kanada, K7L 2V7
        • Cancer Centre of Southeastern Ontario At Kingston General Hospital
      • Ottawa, Ontario, Kanada, K1H 8L1
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal, Quebec, Kanada, H3T 1C5
        • Hopital Sainte Justine
    • Saskatchewan
      • Regina, Saskatchewan, Kanada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Kanada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • Nya Zeeland
      • Auckland, Nya Zeeland, 1
        • Starship Children's Health
      • Christchurch, Nya Zeeland, 8140
        • Christchurch Hospital
  • Schweiz
      • Bern, Schweiz, 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Schweiz, 1205
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Schweiz, 1011
        • Swiss Pediatric Oncology Group Lausanne

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 år till 29 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: terapeutiskt hydrokortison
Läkemedel: vinkristinsulfat
givet IV
Andra namn:
  • Videobandspelare
  • Oncovin
  • LCR
  • NSC #67574
Biologisk: filgrastim
given subcutaneously (SC)
Andra namn:
  • G-CSF
  • Granulocytkolonistimulerande faktor
  • r-metHuG-CSF
  • Neupogen
  • NSC 614629
Läkemedel: cyclophosphamide
IV over 15-30 minutes
Andra namn:
  • CYTOXAN
  • NSC #26271
Läkemedel: cytarabine
IV over 3 hours twice daily
Andra namn:
  • Ara-C
  • Cytosar
  • Cytosin arabinosid
  • NSC #6387
Läkemedel: daunorubicin hydrochloride
IV over 15 minutes
Andra namn:
  • Cerubidin
  • NSC #82151
  • Daunomycin
  • rubidomycin
Läkemedel: dexamethasone
oral twice daily
Andra namn:
  • Dekadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Läkemedel: etoposide
IV over 1 hour
Andra namn:
  • VP-16
  • Etopophos
  • VePesid
  • NSC #141540
Läkemedel: leucovorin calcium
rescue IV over 24 hours
Andra namn:
  • LCV
  • Wellcovorin
  • citrovorum faktor
  • folinsyra
  • NSC 03590
Läkemedel: mercaptopurine
oral
Andra namn:
  • 6 MP
  • Purinethol
  • NSC #000755
  • 6-merkaptopurin
Läkemedel: methotrexate
intramuscularly (IM)
Andra namn:
  • ametopterin
  • MTX
  • NSC #000740
  • Trexall
Läkemedel: pegaspargase
intramuscularly (IM)
Andra namn:
  • Oncaspar
  • PEGLA
  • PEG-L-asparaginas
  • PEG-asparaginas
  • polyetylenglykol-L-asparaginas
  • NSC 624239
Strålning: radiation therapy
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.
Experimentell: 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.
Läkemedel: terapeutiskt hydrokortison
Läkemedel: vinkristinsulfat
givet IV
Andra namn:
  • Videobandspelare
  • Oncovin
  • LCR
  • NSC #67574
Biologisk: filgrastim
given subcutaneously (SC)
Andra namn:
  • G-CSF
  • Granulocytkolonistimulerande faktor
  • r-metHuG-CSF
  • Neupogen
  • NSC 614629
Läkemedel: cyclophosphamide
IV over 15-30 minutes
Andra namn:
  • CYTOXAN
  • NSC #26271
Läkemedel: cytarabine
IV over 3 hours twice daily
Andra namn:
  • Ara-C
  • Cytosar
  • Cytosin arabinosid
  • NSC #6387
Läkemedel: daunorubicin hydrochloride
IV over 15 minutes
Andra namn:
  • Cerubidin
  • NSC #82151
  • Daunomycin
  • rubidomycin
Läkemedel: dexamethasone
oral twice daily
Andra namn:
  • Dekadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Läkemedel: etoposide
IV over 1 hour
Andra namn:
  • VP-16
  • Etopophos
  • VePesid
  • NSC #141540
Läkemedel: leucovorin calcium
rescue IV over 24 hours
Andra namn:
  • LCV
  • Wellcovorin
  • citrovorum faktor
  • folinsyra
  • NSC 03590
Läkemedel: mercaptopurine
oral
Andra namn:
  • 6 MP
  • Purinethol
  • NSC #000755
  • 6-merkaptopurin
Läkemedel: methotrexate
intramuscularly (IM)
Andra namn:
  • ametopterin
  • MTX
  • NSC #000740
  • Trexall
Läkemedel: pegaspargase
intramuscularly (IM)
Andra namn:
  • Oncaspar
  • PEGLA
  • PEG-L-asparaginas
  • PEG-asparaginas
  • polyetylenglykol-L-asparaginas
  • NSC 624239
Strålning: radiation therapy
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Event-free Survival
Tidsram: 3 years
Monitoring of efficacy results will be performed in comparison with historical results.
3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Oncology Group

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • 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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2004

Primärt slutförande (Faktisk)

1 september 2013

Studieregistreringsdatum

Först inskickad

9 november 2004

Först inskickad som uppfyllde QC-kriterierna

8 november 2004

Första postat (Uppskatta)

9 november 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 februari 2017

Senast verifierad

1 februari 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AALL02P2
  • COG-AALL02P2 (Annan identifierare: Children's Oncology Group)
  • NCI-2011-01623 (Annan identifierare: NCI Trial Identifier)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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