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

2017년 2월 14일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

168

단계

  • 해당 없음

연락처 및 위치

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연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 치료용 하이드로코르티손
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • LCR
  • NSC #67574
생물학적: filgrastim
given subcutaneously (SC)
다른 이름들:
  • G-CSF
  • 과립구 콜로니 자극 인자
  • r-metHuG-CSF
  • 뉴포겐
  • NSC 614629
의약품: cyclophosphamide
IV over 15-30 minutes
다른 이름들:
  • 사이톡산
  • NSC #26271
의약품: cytarabine
IV over 3 hours twice daily
다른 이름들:
  • 아라씨
  • 사이토사르
  • 시토신 아라비노시드
  • NSC #6387
의약품: daunorubicin hydrochloride
IV over 15 minutes
다른 이름들:
  • 세루비딘
  • NSC #82151
  • 다우노마이신
  • 루비도마이신
의약품: dexamethasone
oral twice daily
다른 이름들:
  • 데카드론
  • 덱사메스
  • 덱손
  • 헥사드롤
  • NSC #34521
의약품: etoposide
IV over 1 hour
다른 이름들:
  • VP-16
  • 에토포포스
  • 베페시드
  • NSC #141540
의약품: leucovorin calcium
rescue IV over 24 hours
다른 이름들:
  • LCV
  • 웰코보린
  • 시트로보룸 인자
  • 엽산
  • NSC 03590
의약품: mercaptopurine
oral
다른 이름들:
  • 6MP
  • 퓨리네톨
  • NSC #000755
  • 6-메르캅토퓨린
의약품: methotrexate
intramuscularly (IM)
다른 이름들:
  • 아메토프테린
  • MTX
  • NSC #000740
  • 트렉솔
의약품: pegaspargase
intramuscularly (IM)
다른 이름들:
  • 온카스파
  • 페글라
  • PEG-L-아스파라기나아제
  • PEG-아스파라기나아제
  • 폴리에틸렌 글리콜-L-아스파라기나아제
  • NSC 624239
방사능: 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.
실험적: 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.
의약품: 치료용 하이드로코르티손
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • LCR
  • NSC #67574
생물학적: filgrastim
given subcutaneously (SC)
다른 이름들:
  • G-CSF
  • 과립구 콜로니 자극 인자
  • r-metHuG-CSF
  • 뉴포겐
  • NSC 614629
의약품: cyclophosphamide
IV over 15-30 minutes
다른 이름들:
  • 사이톡산
  • NSC #26271
의약품: cytarabine
IV over 3 hours twice daily
다른 이름들:
  • 아라씨
  • 사이토사르
  • 시토신 아라비노시드
  • NSC #6387
의약품: daunorubicin hydrochloride
IV over 15 minutes
다른 이름들:
  • 세루비딘
  • NSC #82151
  • 다우노마이신
  • 루비도마이신
의약품: dexamethasone
oral twice daily
다른 이름들:
  • 데카드론
  • 덱사메스
  • 덱손
  • 헥사드롤
  • NSC #34521
의약품: etoposide
IV over 1 hour
다른 이름들:
  • VP-16
  • 에토포포스
  • 베페시드
  • NSC #141540
의약품: leucovorin calcium
rescue IV over 24 hours
다른 이름들:
  • LCV
  • 웰코보린
  • 시트로보룸 인자
  • 엽산
  • NSC 03590
의약품: mercaptopurine
oral
다른 이름들:
  • 6MP
  • 퓨리네톨
  • NSC #000755
  • 6-메르캅토퓨린
의약품: methotrexate
intramuscularly (IM)
다른 이름들:
  • 아메토프테린
  • MTX
  • NSC #000740
  • 트렉솔
의약품: pegaspargase
intramuscularly (IM)
다른 이름들:
  • 온카스파
  • 페글라
  • PEG-L-아스파라기나아제
  • PEG-아스파라기나아제
  • 폴리에틸렌 글리콜-L-아스파라기나아제
  • NSC 624239
방사능: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Event-free Survival
기간: 3 years
Monitoring of efficacy results will be performed in comparison with historical results.
3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Children's Oncology Group

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
  • 연구 의자: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2004년 11월 1일

기본 완료 (실제)

2013년 9월 1일

연구 등록 날짜

최초 제출

2004년 11월 9일

QC 기준을 충족하는 최초 제출

2004년 11월 8일

처음 게시됨 (추정)

2004년 11월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 3월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 14일

마지막으로 확인됨

2017년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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