- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00021242
Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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New South Wales
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Randwick, New South Wales, Austrália, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Austrália, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Austrália, 4029
- Royal Children's Hospital
-
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South Australia
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North Adelaide, South Australia, Austrália, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, Austrália, 3052
- Royal Children's Hospital
-
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Western Australia
-
Perth, Western Australia, Austrália, 6001
- Princess Margaret Hospital for Children
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-
-
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Alberta
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Calgary, Alberta, Canadá, T2T 5C7
- Alberta Children's Hospital
-
Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute at University of Alberta
-
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British Columbia
-
Vancouver, British Columbia, Canadá, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
-
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Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
-
-
Nova Scotia
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Halifax, Nova Scotia, Canadá, NS B3J 3G9
- IWK Health Centre
-
-
Ontario
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Hamilton, Ontario, Canadá, L8S 4J9
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, Canadá, N6C 2V5
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canadá, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
-
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Quebec
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Montreal, Quebec, Canadá, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
-
Montreal, Quebec, Canadá, H3T 1C5
- Hopital Sainte Justine
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Sainte Foy, Quebec, Canadá, GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
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-
Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
-
Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
-
-
-
-
Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Comprehensive Cancer Center at University of Alabama at Birmingham
-
Mobile, Alabama, Estados Unidos, 36604
- University of South Alabama Cancer Research Institute
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85016
- Phoenix Children's Hospital
-
Tucson, Arizona, Estados Unidos, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
-
-
Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
-
California
-
Downey, California, Estados Unidos, 90242
- Southern California Permanente Medical Group
-
Duarte, California, Estados Unidos, 91010-3000
- City of Hope Comprehensive Cancer Center
-
La Jolla, California, Estados Unidos, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
-
Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Estados Unidos, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
Los Angeles, California, Estados Unidos, 90027-0700
- Children's Hospital Los Angeles
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Los Angeles, California, Estados Unidos, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, Estados Unidos, 93638-8762
- Children's Hospital Central California
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Oakland, California, Estados Unidos, 94609-1809
- Children's Hospital and Research Center - Oakland
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
-
Sacramento, California, Estados Unidos, 95816
- Sutter Cancer Center
-
Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
-
Sacramento, California, Estados Unidos, 95825
- Kaiser Permanente Medical Center - Sacramento
-
San Diego, California, Estados Unidos, 92123-4282
- Children's Hospital and Health Center - San Diego
-
San Diego, California, Estados Unidos, 92120
- Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
-
San Francisco, California, Estados Unidos, 94143
- UCSF Comprehensive Cancer Center
-
Santa Barbara, California, Estados Unidos, 93102
- Santa Barbara Cottage Children's Hospital
-
Santa Clara, California, Estados Unidos, 95051
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
-
Travis Air Force Base, California, Estados Unidos, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, Estados Unidos, 80218
- Children's Hospital Cancer Center
-
-
Connecticut
-
Farmington, Connecticut, Estados Unidos, 06360-7106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
-
New Haven, Connecticut, Estados Unidos, 06520-8064
- Yale Comprehensive Cancer Center at Yale University School of Medicine
-
-
Delaware
-
Wilmington, Delaware, Estados Unidos, 19899
- Alfred I. DuPont Hospital for Children
-
-
District of Columbia
-
Washington, District of Columbia, Estados Unidos, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
-
Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
-
-
Florida
-
Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center Cancer Center
-
Fort Myers, Florida, Estados Unidos, 33908
- Children's Hospital of Southwest Florida
-
Gainesville, Florida, Estados Unidos, 32610-0296
- University of Florida Shands Cancer Center
-
Hollywood, Florida, Estados Unidos, 33021
- Joe DiMaggio Children's Hospital at Memorial
-
Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
-
Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
-
Miami, Florida, Estados Unidos, 33136
- Jackson Memorial Hospital
-
Miami, Florida, Estados Unidos, 33176-2197
- Baptist-South Miami Regional Cancer Program
-
Orlando, Florida, Estados Unidos, 32804
- Florida Hospital Cancer Institute
-
Orlando, Florida, Estados Unidos, 32806
- Nemours Children's Clinic - Orlando
-
Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Children's Hospital
-
St. Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
-
Tampa, Florida, Estados Unidos, 33677-4227
- St. Joseph's Children's Hospital of Tampa
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West Palm Beach, Florida, Estados Unidos, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
-
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Estados Unidos, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Estados Unidos, 31201
- Medical Center of Central Georgia
-
Savannah, Georgia, Estados Unidos, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
-
Hawaii
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Honolulu, Hawaii, Estados Unidos, 96859-5000
- Tripler Army Medical Center
-
Honolulu, Hawaii, Estados Unidos, 96813
- Cancer Research Center of Hawaii
-
-
Idaho
-
Boise, Idaho, Estados Unidos, 83712
- St. Luke's Mountain States Tumor Institute - Boise
-
-
Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
-
Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Estados Unidos, 60601
- University of Chicago Cancer Research Center
-
Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago Cancer Center
-
Oak Lawn, Illinois, Estados Unidos, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, Estados Unidos, 61637
- Saint Jude Midwest Affiliate
-
Springfield, Illinois, Estados Unidos, 62794-9658
- Southern Illinois University School of Medicine
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Indianapolis Hospital
-
Indianapolis, Indiana, Estados Unidos, 46202-5225
- Riley's Children Cancer Center at Riley Hospital for Children
-
-
Iowa
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Des Moines, Iowa, Estados Unidos, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kansas
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Wichita, Kansas, Estados Unidos, 67214
- Wesley Medical Center
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-
Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Estados Unidos, 40202-3830
- Kosair Children's Hospital
-
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Estados Unidos, 70112
- MBCCOP - LSU Health Sciences Center
-
New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Estados Unidos, 04401
- Pediatric Specialty Clinic at Eastern Maine Medical Center
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Scarborough, Maine, Estados Unidos, 04074-9308
- Maine Children's Cancer Program
-
-
Maryland
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Baltimore, Maryland, Estados Unidos, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, Estados Unidos, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Estados Unidos, 21231-7223
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Silver Spring, Maryland, Estados Unidos, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Estados Unidos, 01107
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Worcester, Massachusetts, Estados Unidos, 01655
- UMASS Memorial Cancer Center - University Campus
-
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0914
- University of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, Estados Unidos, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Estados Unidos, 49503
- DeVos Children's Hospital
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Kalamazoo, Michigan, Estados Unidos, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Estados Unidos, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Estados Unidos, 48073-6769
- William Beaumont Hospital - Royal Oak Campus
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
-
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
-
-
Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
-
Saint Louis, Missouri, Estados Unidos, 63104
- Cardinal Glennon Children's Hospital
-
-
Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- Children's Hospital of Omaha
-
Omaha, Nebraska, Estados Unidos, 68198-2168
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
-
-
Nevada
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Las Vegas, Nevada, Estados Unidos, 89109
- Sunrise Hospital and Medical Center
-
-
New Hampshire
-
Lebanon, New Hampshire, Estados Unidos, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
-
New Brunswick, New Jersey, Estados Unidos, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Estados Unidos, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Estados Unidos, 07901
- Valerie Fund Children's Center at Atlantic Health System
-
-
New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87131
- University of New Mexico Cancer Research and Treatment Center
-
-
New York
-
Albany, New York, Estados Unidos, 12208
- Children's Hospital at Albany Medical Center
-
Bronx, New York, Estados Unidos, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Brooklyn, New York, Estados Unidos, 11219
- Maimonides Medical Center
-
Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Medical Center
-
Brooklyn, New York, Estados Unidos, 11212
- Brookdale University Hospital and Medical Center
-
Brooklyn, New York, Estados Unidos, 11201-5493
- Brooklyn Hospital Center
-
New Hyde Park, New York, Estados Unidos, 11040
- Schneider Children's Hospital
-
New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Estados Unidos, 10021
- New York Weill Cornell Cancer Center at Cornell University
-
New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
-
Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Stony Brook, New York, Estados Unidos, 11794-8174
- Long Island Cancer Center at Stony Brook University Hospital
-
Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
-
Valhalla, New York, Estados Unidos, 10595
- New York Medical College
-
-
North Carolina
-
Asheville, North Carolina, Estados Unidos, 28801
- Mission Hospitals - Memorial Campus
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, Estados Unidos, 28233
- Presbyterian Cancer Center at Presbyterian Hospital
-
Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
-
Greenville, North Carolina, Estados Unidos, 27858-4354
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
-
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Ohio
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Akron, Ohio, Estados Unidos, 44308-1062
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
-
Columbus, Ohio, Estados Unidos, 43205-2696
- Columbus Children's Hospital
-
Dayton, Ohio, Estados Unidos, 45404
- Children's Medical Center - Dayton
-
Toledo, Ohio, Estados Unidos, 43601
- Toledo Children's Hospital
-
Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
-
Youngstown, Ohio, Estados Unidos, 44501
- Tod Children's Hospital - Forum Health
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73104
- Children's Hospital at Oklahoma University Medical Center
-
Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Estados Unidos, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
-
Portland, Oregon, Estados Unidos, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
-
-
Pennsylvania
-
Danville, Pennsylvania, Estados Unidos, 17822-1320
- Geisinger Medical Center
-
Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Children's Hospital
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
- St. Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
-
-
Rhode Island
-
Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
-
Columbia, South Carolina, Estados Unidos, 29203
- Palmetto Health South Carolina Cancer Center
-
Greenville, South Carolina, Estados Unidos, 29605
- Children's Hospital of Greenville Hospital System
-
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South Dakota
-
Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Estados Unidos, 57105-1080
- Avera Cancer Institute
-
-
Tennessee
-
Johnson City, Tennessee, Estados Unidos, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
-
Knoxville, Tennessee, Estados Unidos, 37901
- East Tennessee Children's Hospital
-
Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
-
Nashville, Tennessee, Estados Unidos, 37232-6310
- Vanderbilt Children's Hospital
-
-
Texas
-
Amarillo, Texas, Estados Unidos, 79106
- Texas Tech University Health Sciences Center School of Medicine
-
Austin, Texas, Estados Unidos, 78701
- Children's Hospital of Austin
-
Dallas, Texas, Estados Unidos, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, Estados Unidos, 75390-9063
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
-
Galveston, Texas, Estados Unidos, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Estados Unidos, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
Houston, Texas, Estados Unidos, 77030
- Cancer Center at Baylor College of Medicine
-
Lackland Air Force Base, Texas, Estados Unidos, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Estados Unidos, 79410
- Covenant Children's Hospital
-
San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Estados Unidos, 78229-3900
- MBCCOP - South Texas Pediatrics
-
San Antonio, Texas, Estados Unidos, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
-
Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
-
Temple, Texas, Estados Unidos, 76508
- Center for Cancer Prevention and Care at Scott and White Clinic
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute at University of Utah
-
-
Vermont
-
Burlington, Vermont, Estados Unidos, 05401-3498
- Vermont Cancer Center at University of Vermont
-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, Estados Unidos, 22042-3300
- Inova Fairfax Hospital
-
Norfolk, Virginia, Estados Unidos, 23507
- Children's Hospital of The King's Daughters
-
Portsmouth, Virginia, Estados Unidos, 23708-5100
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Estados Unidos, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
-
Roanoke, Virginia, Estados Unidos, 24029
- Carilion Medical Center for Children at Roanoke Community Hospital
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
Seattle, Washington, Estados Unidos, 98109-1024
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Estados Unidos, 98112
- Group Health Central Hospital
-
Spokane, Washington, Estados Unidos, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Estados Unidos, 98415-0299
- Mary Bridge Children's Hospital and Health Center - Tacoma
-
Tacoma, Washington, Estados Unidos, 98431-0001
- Madigan Army Medical Center
-
-
West Virginia
-
Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington, West Virginia, Estados Unidos, 25701
- Cabell Huntington Hospital
-
Morgantown, West Virginia, Estados Unidos, 26506-9300
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
-
-
Wisconsin
-
Green Bay, Wisconsin, Estados Unidos, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Estados Unidos, 54301
- Bellin Memorial Hospital
-
Green Bay, Wisconsin, Estados Unidos, 54307-9070
- St. Vincent Hospital Regional Cancer Center
-
La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Estados Unidos, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Marshfield, Wisconsin, Estados Unidos, 54449
- CCOP - Marshfield Clinic Research Foundation
-
Marshfield, Wisconsin, Estados Unidos, 54449-5772
- Marshfield Clinic - Marshfield Center
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center
-
-
-
-
-
Groningen, Holanda, 9700 RB
- University Medical Center Groningen
-
-
-
-
-
Auckland, Nova Zelândia
- Starship Children's Health
-
-
-
-
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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
-
-
-
-
-
Bern, Suíça, CH 3010
- Swiss Pediatric Oncology Group Bern
-
Geneva, Suíça, CH 1211
- Swiss Pediatric Oncology Group Geneva
-
Lausanne, Suíça, CH 1011
- Swiss Pediatric Oncology Group Lausanne
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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.
|
Continuous IV infusion
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Response to therapy
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Janet Franklin, MD, MPH, Children's Hospital Los Angeles
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ADVL0023
- COG-ADVL0023 (Outro identificador: Children's Oncology Group)
- CCG-09715 (Outro identificador: Children's Cancer Group)
- CDR0000068762 (Outro identificador: Clinical Trials.gov)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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