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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00021242
First received: July 11, 2001
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Response to therapy [ Time Frame: At any time during protocol therapy ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: August 2002
Study Completion Date: September 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: docetaxel
Continuous IV infusion
Other Names:
  • Taxotere®
  • NSC #628503

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021242

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

Additional Information:
Publications:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00021242     History of Changes
Other Study ID Numbers: ADVL0023, COG-ADVL0023, CCG-09715, CDR0000068762
Study First Received: July 11, 2001
Last Updated: August 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
childhood acute promyelocytic leukemia (M3)

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 02, 2014