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S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

5. marts 2015 opdateret af: Southwest Oncology Group

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia.

Studieoversigt

Status

Afsluttet

Betingelser

Leukæmi

Intervention / Behandling

Medicin: nelarabine

Detaljeret beskrivelse

OBJECTIVES:

Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78.
Determine the frequency and severity of toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18 months.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Mobile, Alabama, Forenede Stater, 36688
    - MBCCOP - Gulf Coast
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85006-2726
    - CCOP - Western Regional, Arizona
  - Phoenix, Arizona, Forenede Stater, 85012
    - Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
  - Tucson, Arizona, Forenede Stater, 85723
    - Veterans Affairs Medical Center - Tucson
  - Tucson, Arizona, Forenede Stater, 85724
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Duarte, California, Forenede Stater, 91010
    - City of Hope Comprehensive Cancer Center
  - Long Beach, California, Forenede Stater, 90822
    - Veterans Affairs Medical Center - Long Beach
  - Los Angeles, California, Forenede Stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Forenede Stater, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Los Angeles, California, Forenede Stater, 90073
    - Veterans Affairs Medical Center - West Los Angeles
  - Martinez, California, Forenede Stater, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, Forenede Stater, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center
  - Sacramento, California, Forenede Stater, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, Forenede Stater, 94143-0128
    - UCSF Comprehensive Cancer Center
  - Santa Rosa, California, Forenede Stater, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Stanford, California, Forenede Stater, 94305
    - Stanford University
  - Travis Air Force Base, California, Forenede Stater, 94535
    - David Grant Medical Center
- Colorado
  - Denver, Colorado, Forenede Stater, 80220
    - Veterans Affairs Medical Center - Denver
  - Denver, Colorado, Forenede Stater, 80010
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20060
    - MBCCOP - Howard University Cancer Center
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30342-1701
    - CCOP - Atlanta Regional
  - Fort Gordon, Georgia, Forenede Stater, 30905-5650
    - Dwight David Eisenhower Army Medical Center
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96859-5000
    - Tripler Army Medical Center
  - Honolulu, Hawaii, Forenede Stater, 96813
    - MBCCOP - Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813-2424
    - Cancer Research Center of Hawaii
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612-7323
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, Forenede Stater, 60612
    - Veterans Affairs Medical Center - Chicago (Westside Hospital)
  - Decatur, Illinois, Forenede Stater, 62526
    - CCOP - Central Illinois
  - Hines, Illinois, Forenede Stater, 60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood, Illinois, Forenede Stater, 60153-5500
    - Loyola University Medical Center
- Iowa
  - Davenport, Iowa, Forenede Stater, 52804
    - Genesis Medical Center
- Kansas
  - Kansas City, Kansas, Forenede Stater, 66160-7353
    - University of Kansas Medical Center
  - Wichita, Kansas, Forenede Stater, 67214-3882
    - CCOP - Wichita
  - Wichita, Kansas, Forenede Stater, 67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
  - Lexington, Kentucky, Forenede Stater, 40502-2236
    - Veterans Affairs Medical Center - Lexington
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, Forenede Stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, Forenede Stater, 71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport, Louisiana, Forenede Stater, 71130
    - Veterans Affairs Medical Center - Shreveport
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02118
    - Boston Medical Center
  - Jamaica Plain, Massachusetts, Forenede Stater, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Ann Arbor, Michigan, Forenede Stater, 48109-0912
    - University Of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, Forenede Stater, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Detroit, Michigan, Forenede Stater, 48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids
  - Royal Oak, Michigan, Forenede Stater, 48073-6769
    - CCOP - Beaumont
  - Southfield, Michigan, Forenede Stater, 48075-9975
    - Providence Hospital - Southfield
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55805
    - CCOP - Duluth
- Mississippi
  - Biloxi, Mississippi, Forenede Stater, 39531-2410
    - Veterans Affairs Medical Center - Biloxi
  - Jackson, Mississippi, Forenede Stater, 39216-4505
    - University of Mississippi Medical Center
  - Jackson, Mississippi, Forenede Stater, 39216
    - Veterans Affairs Medical Center - Jackson
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, Forenede Stater, 63110
    - St. Louis University Health Sciences Center
  - Springfield, Missouri, Forenede Stater, 65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque, New Mexico, Forenede Stater, 87131
    - MBCCOP - University of New Mexico HSC
- New York
  - Albany, New York, Forenede Stater, 12208
    - Veterans Affairs Medical Center - Albany
  - New York, New York, Forenede Stater, 10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
- North Carolina
  - Winston-Salem, North Carolina, Forenede Stater, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cincinnati, Ohio, Forenede Stater, 45267-0501
    - Barrett Cancer Center
  - Cleveland, Ohio, Forenede Stater, 44195-9001
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, Forenede Stater, 43206
    - CCOP - Columbus
  - Dayton, Ohio, Forenede Stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Forenede Stater, 45429
    - CCOP - Dayton
  - Toledo, Ohio, Forenede Stater, 43623-3456
    - CCOP - Toledo Community Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Veterans Affairs Medical Center - Oklahoma City
- Oregon
  - Portland, Oregon, Forenede Stater, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, Forenede Stater, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Forenede Stater, 97201-3098
    - Oregon Cancer Institute
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Charleston, South Carolina, Forenede Stater, 29401-5799
    - Veterans Affairs Medical Center - Charleston
  - Greenville, South Carolina, Forenede Stater, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - CCOP - Upstate Carolina
- Tennessee
  - Memphis, Tennessee, Forenede Stater, 38103
    - University of Tennessee Cancer Institute
  - Memphis, Tennessee, Forenede Stater, 38104
    - Danville Radiation Therapy Center
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Harrington Cancer Center
  - Amarillo, Texas, Forenede Stater, 79106
    - Veterans Affairs Medical Center - Amarillo
  - Dallas, Texas, Forenede Stater, 75216
    - Veterans Affairs Medical Center - Dallas
  - Fort Sam Houston, Texas, Forenede Stater, 78234-6200
    - Brooke Army Medical Center
  - Galveston, Texas, Forenede Stater, 77555-0565
    - University of Texas Medical Branch
  - Houston, Texas, Forenede Stater, 77030
    - Veterans Affairs Medical Center - Houston
  - San Antonio, Texas, Forenede Stater, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Forenede Stater, 78229
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - Temple, Texas, Forenede Stater, 76504
    - Veterans Affairs Medical Center - Temple
  - Temple, Texas, Forenede Stater, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84148
    - Veterans Affairs Medical Center - Salt Lake City
  - Salt Lake City, Utah, Forenede Stater, 84112-5550
    - Huntsman Cancer Institute
- Vermont
  - Burlington, Vermont, Forenede Stater, 05401
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Richmond, Virginia, Forenede Stater, 23298-0037
    - MBCCOP - Massey Cancer Center
- Washington
  - Seattle, Washington, Forenede Stater, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, Forenede Stater, 98108
    - Veterans Affairs Medical Center - Seattle
  - Seattle, Washington, Forenede Stater, 98104
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Tacoma, Washington, Forenede Stater, 98431-5000
    - Madigan Army Medical Center
  - Tacoma, Washington, Forenede Stater, 98405-0986
    - CCOP - Northwest

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Diagnosis of acute lymphocytic leukemia (ALL)
- FAB class L1-L2
Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)
- Coexpression of myeloid antigens CD13 or CD33 allowed
Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed
- CD3 and myeloperoxidase marker negative
Meeting 1 of the following criteria for recurrent/refractory disease:
- Refractory to standard induction regimen including at least vincristine and prednisone
- Recurrence after response after prior induction therapy
- Recurrence and failure on subsequent treatment
No CNS involvement
Must be registered on SWOG-S9910 and SWOG-9007

PATIENT CHARACTERISTICS:

Age:

16 and over

Performance status:

Zubrod 0-3

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT or SGPT no greater than 3 times ULN

Renal:

Creatinine no greater than 2 times ULN

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No grade 2 or greater neuropathy
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
CR Tidsramme: Efter afsluttet induktionsterapi	Efter afsluttet induktionsterapi

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Steven E. Coutre, MD, Stanford University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2000

Primær færdiggørelse (Faktiske)

1. juni 2004

Studieafslutning (Faktiske)

1. juli 2004

Datoer for studieregistrering

Først indsendt

5. juli 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

S0010 (Anden identifikator: SWOG)
U10CA032102 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .