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Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia

7 août 2014 mis à jour par: Children's Oncology Group

A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

OBJECTIVES:

  • Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 1 year.

Type d'étude

Interventionnel

Inscription (Réel)

12

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Australie
    • New South Wales
      • Randwick, New South Wales, Australie, 2031
        • Sydney Children's Hospital
      • Westmead, New South Wales, Australie, 2145
        • Children's Hospital at Westmead
    • Queensland
      • Brisbane, Queensland, Australie, 4029
        • Royal Children's Hospital
    • South Australia
      • North Adelaide, South Australia, Australie, 5006
        • Women's and Children's Hospital
    • Victoria
      • Parkville, Victoria, Australie, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australie, 6001
        • Princess Margaret Hospital for Children
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, NS B3J 3G9
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • McMaster Children's Hospital at Hamilton Health Sciences
      • London, Ontario, Canada, N6C 2V5
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
      • Sainte Foy, Quebec, Canada, GIV 4G2
        • Centre de Recherche du Centre Hospitalier de l'Universite Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • Nouvelle-Zélande
      • Auckland, Nouvelle-Zélande
        • Starship Children's Health
  • Pays-Bas
      • Groningen, Pays-Bas, 9700 RB
        • University Medical Center Groningen
  • Porto Rico
      • San Juan, Porto Rico, 00936-5067
        • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
      • Santurce, Porto Rico, 00912
        • San Jorge Children's Hospital
  • Suisse
      • Bern, Suisse, CH 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Suisse, CH 1211
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Suisse, CH 1011
        • Swiss Pediatric Oncology Group Lausanne
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Comprehensive Cancer Center at University of Alabama at Birmingham
      • Mobile, Alabama, États-Unis, 36604
        • University of South Alabama Cancer Research Institute
    • Arizona
      • Phoenix, Arizona, États-Unis, 85016
        • Phoenix Children's Hospital
      • Tucson, Arizona, États-Unis, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, États-Unis, 90242
        • Southern California Permanente Medical Group
      • Duarte, California, États-Unis, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, États-Unis, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Loma Linda, California, États-Unis, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, États-Unis, 90801-1428
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, États-Unis, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, États-Unis, 90027-0700
        • Children's Hospital Los Angeles
      • Los Angeles, California, États-Unis, 90048
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Madera, California, États-Unis, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, États-Unis, 94609-1809
        • Children's Hospital and Research Center - Oakland
      • Orange, California, États-Unis, 92868
        • Children's Hospital of Orange County
      • Orange, California, États-Unis, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • Palo Alto, California, États-Unis, 94304
        • Lucile Packard Children's Hospital at Stanford University Medical Center
      • Sacramento, California, États-Unis, 95816
        • Sutter Cancer Center
      • Sacramento, California, États-Unis, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, États-Unis, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Diego, California, États-Unis, 92123-4282
        • Children's Hospital and Health Center - San Diego
      • San Diego, California, États-Unis, 92120
        • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
      • San Francisco, California, États-Unis, 94143
        • UCSF Comprehensive Cancer Center
      • Santa Barbara, California, États-Unis, 93102
        • Santa Barbara Cottage Children's Hospital
      • Santa Clara, California, États-Unis, 95051
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
      • Travis Air Force Base, California, États-Unis, 94535
        • General Robert Huyser Cancer Center at David Grant Medical Center
    • Colorado
      • Denver, Colorado, États-Unis, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, États-Unis, 80218
        • Children's Hospital Cancer Center
    • Connecticut
      • Farmington, Connecticut, États-Unis, 06360-7106
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
      • New Haven, Connecticut, États-Unis, 06520-8064
        • Yale Comprehensive Cancer Center at Yale University School of Medicine
    • Delaware
      • Wilmington, Delaware, États-Unis, 19899
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, États-Unis, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, États-Unis, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale, Florida, États-Unis, 33316
        • Broward General Medical Center Cancer Center
      • Fort Myers, Florida, États-Unis, 33908
        • Children's Hospital of Southwest Florida
      • Gainesville, Florida, États-Unis, 32610-0296
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, États-Unis, 33021
        • Joe DiMaggio Children's Hospital at Memorial
      • Jacksonville, Florida, États-Unis, 32207
        • Nemours Children's Clinic
      • Miami, Florida, États-Unis, 33155
        • Miami Children's Hospital
      • Miami, Florida, États-Unis, 33136
        • Jackson Memorial Hospital
      • Miami, Florida, États-Unis, 33176-2197
        • Baptist-South Miami Regional Cancer Program
      • Orlando, Florida, États-Unis, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, États-Unis, 32806
        • Nemours Children's Clinic - Orlando
      • Pensacola, Florida, États-Unis, 32504
        • Sacred Heart Children's Hospital
      • St. Petersburg, Florida, États-Unis, 33701
        • All Children's Hospital
      • Tampa, Florida, États-Unis, 33677-4227
        • St. Joseph's Children's Hospital of Tampa
      • West Palm Beach, Florida, États-Unis, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, États-Unis, 30342
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
      • Augusta, Georgia, États-Unis, 30912-4000
        • MBCCOP-Medical College of Georgia Cancer Center
      • Macon, Georgia, États-Unis, 31201
        • Medical Center of Central Georgia
      • Savannah, Georgia, États-Unis, 31405
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, États-Unis, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, États-Unis, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
        • Rush University Medical Center
      • Chicago, Illinois, États-Unis, 60614
        • Children's Memorial Hospital - Chicago
      • Chicago, Illinois, États-Unis, 60601
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, États-Unis, 60612
        • University of Illinois at Chicago Cancer Center
      • Oak Lawn, Illinois, États-Unis, 60453
        • Advocate Hope Children's Hospital
      • Park Ridge, Illinois, États-Unis, 60068-1174
        • Lutheran General Cancer Care Center
      • Peoria, Illinois, États-Unis, 61637
        • Saint Jude Midwest Affiliate
      • Springfield, Illinois, États-Unis, 62794-9658
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46260
        • St. Vincent Indianapolis Hospital
      • Indianapolis, Indiana, États-Unis, 46202-5225
        • Riley's Children Cancer Center at Riley Hospital for Children
    • Iowa
      • Des Moines, Iowa, États-Unis, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, États-Unis, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Wichita, Kansas, États-Unis, 67214
        • Wesley Medical Center
    • Kentucky
      • Lexington, Kentucky, États-Unis, 40536-0284
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, États-Unis, 40202-3830
        • Kosair Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70118
        • Children's Hospital of New Orleans
      • New Orleans, Louisiana, États-Unis, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, États-Unis, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
      • New Orleans, Louisiana, États-Unis, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
    • Maine
      • Bangor, Maine, États-Unis, 04401
        • Pediatric Specialty Clinic at Eastern Maine Medical Center
      • Scarborough, Maine, États-Unis, 04074-9308
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, États-Unis, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
      • Baltimore, Maryland, États-Unis, 21201-1595
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Baltimore, Maryland, États-Unis, 21231-7223
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Silver Spring, Maryland, États-Unis, 20910
        • Walter Reed Army Medical Center
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, États-Unis, 02111
        • Floating Hospital for Children
      • Springfield, Massachusetts, États-Unis, 01107
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
      • Worcester, Massachusetts, États-Unis, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109-0914
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, États-Unis, 48201
        • Children's Hospital of Michigan
      • Detroit, Michigan, États-Unis, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Flint, Michigan, États-Unis, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, États-Unis, 49503
        • DeVos Children's Hospital
      • Kalamazoo, Michigan, États-Unis, 49007-5364
        • Bronson Methodist Hospital
      • Lansing, Michigan, États-Unis, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Royal Oak, Michigan, États-Unis, 48073-6769
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Duluth, Minnesota, États-Unis, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Minneapolis, Minnesota, États-Unis, 55404
        • Children's Hospitals and Clinics - Minneapolis/St. Paul
      • Rochester, Minnesota, États-Unis, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, États-Unis, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, États-Unis, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, États-Unis, 63110
        • St. Louis Children's Hospital
      • Saint Louis, Missouri, États-Unis, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, États-Unis, 68114
        • Children's Hospital of Omaha
      • Omaha, Nebraska, États-Unis, 68198-2168
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89109
        • Sunrise Hospital and Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, États-Unis, 03756
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, États-Unis, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, États-Unis, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, États-Unis, 07112-2094
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, États-Unis, 07503
        • St. Joseph's Hospital and Medical Center
      • Summit, New Jersey, États-Unis, 07901
        • Valerie Fund Children's Center at Atlantic Health System
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87131
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Albany, New York, États-Unis, 12208
        • Children's Hospital at Albany Medical Center
      • Bronx, New York, États-Unis, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, États-Unis, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, États-Unis, 11203
        • SUNY Downstate Medical Center
      • Brooklyn, New York, États-Unis, 11212
        • Brookdale University Hospital and Medical Center
      • Brooklyn, New York, États-Unis, 11201-5493
        • Brooklyn Hospital Center
      • New Hyde Park, New York, États-Unis, 11040
        • Schneider Children's Hospital
      • New York, New York, États-Unis, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, États-Unis, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, États-Unis, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • New York, New York, États-Unis, 10029
        • Mount Sinai Medical Center
      • Rochester, New York, États-Unis, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, États-Unis, 11794-8174
        • Long Island Cancer Center at Stony Brook University Hospital
      • Syracuse, New York, États-Unis, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, États-Unis, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, États-Unis, 28801
        • Mission Hospitals - Memorial Campus
      • Chapel Hill, North Carolina, États-Unis, 27599
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, États-Unis, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, États-Unis, 28233
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, États-Unis, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, États-Unis, 27858-4354
        • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
    • North Dakota
      • Fargo, North Dakota, États-Unis, 58103-4940
        • Dakota Cancer Institute at Innovis Health - Dakota Clinic
    • Ohio
      • Akron, Ohio, États-Unis, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, États-Unis, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, États-Unis, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, États-Unis, 44106-5065
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus, Ohio, États-Unis, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, États-Unis, 45404
        • Children's Medical Center - Dayton
      • Toledo, Ohio, États-Unis, 43601
        • Toledo Children's Hospital
      • Toledo, Ohio, États-Unis, 43608
        • St. Vincent Mercy Medical Center
      • Youngstown, Ohio, États-Unis, 44501
        • Tod Children's Hospital - Forum Health
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • Children's Hospital at Oklahoma University Medical Center
      • Tulsa, Oklahoma, États-Unis, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Portland, Oregon, États-Unis, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, États-Unis, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, États-Unis, 97239-3098
        • Doernbecher Children's Hospital at Oregon Health & Science University
    • Pennsylvania
      • Danville, Pennsylvania, États-Unis, 17822-1320
        • Geisinger Medical Center
      • Hershey, Pennsylvania, États-Unis, 17033
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, États-Unis, 19134-1095
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425-0721
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, États-Unis, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, États-Unis, 29605
        • Children's Hospital of Greenville Hospital System
    • South Dakota
      • Sioux Falls, South Dakota, États-Unis, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, États-Unis, 57105-1080
        • Avera Cancer Institute
    • Tennessee
      • Johnson City, Tennessee, États-Unis, 37614-0622
        • East Tennessee State University Cancer Center at Johnson City Medical Center
      • Knoxville, Tennessee, États-Unis, 37901
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, États-Unis, 38105
        • St. Jude Children's Research Hospital
      • Nashville, Tennessee, États-Unis, 37232-6310
        • Vanderbilt Children's Hospital
    • Texas
      • Amarillo, Texas, États-Unis, 79106
        • Texas Tech University Health Sciences Center School of Medicine
      • Austin, Texas, États-Unis, 78701
        • Children's Hospital of Austin
      • Dallas, Texas, États-Unis, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, États-Unis, 75390-9063
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, États-Unis, 76104
        • Cook Children's Medical Center - Fort Worth
      • Galveston, Texas, États-Unis, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, États-Unis, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
      • Houston, Texas, États-Unis, 77030
        • Cancer Center at Baylor College of Medicine
      • Lackland Air Force Base, Texas, États-Unis, 78236-5300
        • Wilford Hall Medical Center
      • Lubbock, Texas, États-Unis, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, États-Unis, 78207
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, États-Unis, 78229-3900
        • MBCCOP - South Texas Pediatrics
      • San Antonio, Texas, États-Unis, 78229-3902
        • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
      • Temple, Texas, États-Unis, 76508
        • CCOP - Scott and White Hospital
      • Temple, Texas, États-Unis, 76508
        • Center for Cancer Prevention and Care at Scott and White Clinic
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • Huntsman Cancer Institute at University of Utah
    • Vermont
      • Burlington, Vermont, États-Unis, 05401-3498
        • Vermont Cancer Center at University of Vermont
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22908
        • University of Virginia Cancer Center
      • Falls Church, Virginia, États-Unis, 22042-3300
        • Inova Fairfax Hospital
      • Norfolk, Virginia, États-Unis, 23507
        • Children's Hospital of The King's Daughters
      • Portsmouth, Virginia, États-Unis, 23708-5100
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, États-Unis, 23298-0121
        • Massey Cancer Center at Virginia Commonwealth University
      • Roanoke, Virginia, États-Unis, 24029
        • Carilion Medical Center for Children at Roanoke Community Hospital
    • Washington
      • Seattle, Washington, États-Unis, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Seattle, Washington, États-Unis, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, États-Unis, 98112
        • Group Health Central Hospital
      • Spokane, Washington, États-Unis, 99210-0248
        • Deaconess Medical Center
      • Tacoma, Washington, États-Unis, 98415-0299
        • Mary Bridge Children's Hospital and Health Center - Tacoma
      • Tacoma, Washington, États-Unis, 98431-0001
        • Madigan Army Medical Center
    • West Virginia
      • Charleston, West Virginia, États-Unis, 25302
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, États-Unis, 25701
        • Cabell Huntington Hospital
      • Morgantown, West Virginia, États-Unis, 26506-9300
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, États-Unis, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Green Bay, Wisconsin, États-Unis, 54301
        • Bellin Memorial Hospital
      • Green Bay, Wisconsin, États-Unis, 54307-9070
        • St. Vincent Hospital Regional Cancer Center
      • La Crosse, Wisconsin, États-Unis, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, États-Unis, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, États-Unis, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Marshfield, Wisconsin, États-Unis, 54449-5772
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Midwest Children's Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 21 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute lymphoblastic or acute myeloid leukemia

    • M3 bone marrow relapse required
  • Refractory to conventional chemotherapy
  • No extramedullary disease at relapse

PATIENT CHARACTERISTICS:

Age:

  • 21 and under at time of initial diagnosis

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 7 days since prior biologic therapy and recovered
  • At least 6 months since prior allogeneic stem cell transplantation
  • No concurrent immunomodulating agents during first 2 courses of therapy
  • No concurrent routine filgrastim (G-CSF)

Chemotherapy:

  • See Disease Characteristics
  • At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
  • No prior paclitaxel or docetaxel
  • No other concurrent chemotherapy during first 2 courses of therapy

Endocrine therapy:

  • No concurrent corticosteroid therapy except dexamethasone, low-dose hydrocortisone to treat allergic reactions, or treatment for adrenal crisis

Radiotherapy:

  • Recovered from prior radiotherapy
  • At least 2 weeks since prior palliative local radiotherapy
  • At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of the pelvis
  • At least 6 weeks since prior substantial bone marrow radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Relapsed or Refractory ALL, AML
Docetaxel 60 mg/m^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest.
Médicament: docetaxel
Continuous IV infusion
Autres noms:
  • Taxotère®
  • NSC #628503

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Response to therapy
Délai: At any time during protocol therapy
The levels of pro- and anti-apoptotic proteins will be evaluated in specimens taken before and after administration of docetaxel, at the end of therapy and at the time of relapse. The average values and variance of these levels will be used to design further investigations. The pre- and post- docetaxel levels will be compared using the difference of these two values for each patient. The change in level will be assessed using a paired t-test with an appropriate transformation for normality.
At any time during protocol therapy

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Children's Oncology Group

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chaise d'étude: Janet Franklin, MD, MPH, Children's Hospital Los Angeles

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2002

Achèvement primaire (Réel)

1 mars 2006

Achèvement de l'étude (Réel)

1 septembre 2006

Dates d'inscription aux études

Première soumission

11 juillet 2001

Première soumission répondant aux critères de contrôle qualité

26 janvier 2003

Première publication (Estimation)

27 janvier 2003

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

8 août 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 août 2014

Dernière vérification

1 août 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ADVL0023
  • COG-ADVL0023 (Autre identifiant: Children's Oncology Group)
  • CCG-09715 (Autre identifiant: Children's Cancer Group)
  • CDR0000068762 (Autre identifiant: Clinical Trials.gov)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Leucémie

Essais cliniques sur docetaxel

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Singapore

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

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