Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

12

Study ID:

NCT00021242

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 217 Locations for this study

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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
University of South Alabama Cancer Research Institute
Mobile Alabama, 36604, United States
Phoenix Children's Hospital
Phoenix Arizona, 85016, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson Arizona, 85724, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Southern California Permanente Medical Group
Downey California, 90242, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda California, 92354, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach California, 90801, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles California, 90095, United States
Children's Hospital Central California
Madera California, 93638, United States
Children's Hospital and Research Center - Oakland
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange California, 92868, United States
Children's Hospital of Orange County
Orange California, 92868, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto California, 94304, United States
Sutter Cancer Center
Sacramento California, 95816, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
Kaiser Permanente Medical Center - Sacramento
Sacramento California, 95825, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego California, 92120, United States
Children's Hospital and Health Center - San Diego
San Diego California, 92123, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94143, United States
Santa Barbara Cottage Children's Hospital
Santa Barbara California, 93102, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara California, 95051, United States
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base California, 94535, United States
Children's Hospital Cancer Center
Denver Colorado, 80218, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington Connecticut, 06360, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven Connecticut, 06520, United States
Alfred I. duPont Hospital for Children
Wilmington Delaware, 19899, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
Broward General Medical Center Cancer Center
Fort Lauderdale Florida, 33316, United States
Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood Florida, 33021, United States
Nemours Children's Clinic
Jacksonville Florida, 32207, United States
Jackson Memorial Hospital
Miami Florida, 33136, United States
Miami Children's Hospital
Miami Florida, 33155, United States
Baptist-South Miami Regional Cancer Program
Miami Florida, 33176, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Nemours Children's Clinic - Orlando
Orlando Florida, 32806, United States
Sacred Heart Children's Hospital
Pensacola Florida, 32504, United States
All Children's Hospital
St. Petersburg Florida, 33701, United States
St. Joseph's Children's Hospital of Tampa
Tampa Florida, 33677, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach Florida, 33407, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta Georgia, 30342, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta Georgia, 30912, United States
Medical Center of Central Georgia
Macon Georgia, 31201, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31405, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
St. Luke's Mountain States Tumor Institute - Boise
Boise Idaho, 83712, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60601, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Illinois at Chicago Cancer Center
Chicago Illinois, 60612, United States
Children's Memorial Hospital - Chicago
Chicago Illinois, 60614, United States
Advocate Hope Children's Hospital
Oak Lawn Illinois, 60453, United States
Lutheran General Cancer Care Center
Park Ridge Illinois, 60068, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62794, United States
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis Indiana, 46202, United States
St. Vincent Indianapolis Hospital
Indianapolis Indiana, 46260, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
Kosair Children's Hospital
Louisville Kentucky, 40202, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans Louisiana, 70112, United States
Children's Hospital of New Orleans
New Orleans Louisiana, 70118, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Pediatric Specialty Clinic at Eastern Maine Medical Center
Bangor Maine, 04401, United States
Maine Children's Cancer Program
Scarborough Maine, 04074, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore Maryland, 21215, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Walter Reed Army Medical Center
Silver Spring Maryland, 20910, United States
Floating Hospital for Children
Boston Massachusetts, 02111, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield Massachusetts, 01107, United States
UMASS Memorial Cancer Center - University Campus
Worcester Massachusetts, 01655, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Children's Hospital of Michigan
Detroit Michigan, 48201, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48503, United States
DeVos Children's Hospital
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing Michigan, 48910, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak Michigan, 48073, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States
Children's Hospitals and Clinics - Minneapolis/St. Paul
Minneapolis Minnesota, 55404, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Children's Mercy Hospital
Kansas City Missouri, 64108, United States
Cardinal Glennon Children's Hospital
Saint Louis Missouri, 63104, United States
St. Louis Children's Hospital
Saint Louis Missouri, 63110, United States
Children's Hospital of Omaha
Omaha Nebraska, 68114, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Sunrise Hospital and Medical Center
Las Vegas Nevada, 89109, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
St. Joseph's Hospital and Medical Center
Paterson New Jersey, 07503, United States
Valerie Fund Children's Center at Atlantic Health System
Summit New Jersey, 07901, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque New Mexico, 87131, United States
Children's Hospital at Albany Medical Center
Albany New York, 12208, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx New York, 10461, United States
Brooklyn Hospital Center
Brooklyn New York, 11201, United States
SUNY Downstate Medical Center
Brooklyn New York, 11203, United States
Brookdale University Hospital and Medical Center
Brooklyn New York, 11212, United States
Maimonides Medical Center
Brooklyn New York, 11219, United States
Schneider Children's Hospital
New Hyde Park New York, 11040, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Weill Cornell Cancer Center at Cornell University
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York New York, 10032, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook New York, 11794, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
New York Medical College
Valhalla New York, 10595, United States
Mission Hospitals - Memorial Campus
Asheville North Carolina, 28801, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville North Carolina, 27858, United States
Dakota Cancer Institute at Innovis Health - Dakota Clinic
Fargo North Dakota, 58103, United States
Children's Hospital Medical Center of Akron
Akron Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Columbus Children's Hospital
Columbus Ohio, 43205, United States
Children's Medical Center - Dayton
Dayton Ohio, 45404, United States
Toledo Children's Hospital
Toledo Ohio, 43601, United States
St. Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
Tod Children's Hospital - Forum Health
Youngstown Ohio, 44501, United States
Children's Hospital at Oklahoma University Medical Center
Oklahoma City Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
CCOP - Columbia River Oncology Program
Portland Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland Oregon, 97227, United States
Doernbecher Children's Hospital at Oregon Health & Science University
Portland Oregon, 97239, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Children's Hospital
Hershey Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
St. Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States
Palmetto Health South Carolina Cancer Center
Columbia South Carolina, 29203, United States
Children's Hospital of Greenville Hospital System
Greenville South Carolina, 29605, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City Tennessee, 37614, United States
East Tennessee Children's Hospital
Knoxville Tennessee, 37901, United States
St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Vanderbilt Children's Hospital
Nashville Tennessee, 37232, United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo Texas, 79106, United States
Children's Hospital of Austin
Austin Texas, 78701, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
Cook Children's Medical Center - Fort Worth
Fort Worth Texas, 76104, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
M.D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
Cancer Center at Baylor College of Medicine
Houston Texas, 77030, United States
Wilford Hall Medical Center
Lackland Air Force Base Texas, 78236, United States
Covenant Children's Hospital
Lubbock Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78207, United States
MBCCOP - South Texas Pediatrics
San Antonio Texas, 78229, United States
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
San Antonio Texas, 78229, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Center for Cancer Prevention and Care at Scott and White Clinic
Temple Texas, 76508, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah, 84112, United States
Vermont Cancer Center at University of Vermont
Burlington Vermont, 05401, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
INOVA Fairfax Hospital
Falls Church Virginia, 22042, United States
Children's Hospital of the King's Daughters
Norfolk Virginia, 23507, United States
Naval Medical Center - Portsmouth
Portsmouth Virginia, 23708, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond Virginia, 23298, United States
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke Virginia, 24029, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle Washington, 98105, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Deaconess Medical Center
Spokane Washington, 99210, United States
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma Washington, 98415, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston West Virginia, 25302, United States
Cabell Huntington Hospital
Huntington West Virginia, 25701, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown West Virginia, 26506, United States
Bellin Memorial Hospital
Green Bay Wisconsin, 54301, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54301, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield Wisconsin, 54449, United States
Midwest Children's Cancer Center
Milwaukee Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick New South Wales, 2031, Australia
Children's Hospital at Westmead
Westmead New South Wales, 2145, Australia
Royal Children's Hospital
Brisbane Queensland, 4029, Australia
Women's and Children's Hospital
North Adelaide South Australia, 5006, Australia
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth Western Australia, 6001, Australia
Alberta Children's Hospital
Calgary Alberta, T2T 5, Canada
Cross Cancer Institute at University of Alberta
Edmonton Alberta, T6G 1, Canada
Children's & Women's Hospital of British Columbia
Vancouver British Columbia, V6H 3, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Janeway Children's Health and Rehabilitation Centre
St. John's Newfoundland and Labrador, A1B 3, Canada
IWK Health Centre
Halifax Nova Scotia, NS B3, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8S 4, Canada
Children's Hospital of Western Ontario
London Ontario, N6C 2, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal Quebec, H3H 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte Foy Quebec, GIV 4, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon Saskatchewan, S7N 4, Canada
University Medical Center Groningen
Groningen , 9700 , Netherlands
Starship Children's Health
Auckland , , New Zealand
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
San Juan , 00936, Puerto Rico
San Jorge Children's Hospital
Santurce , 00912, Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern , CH 30, Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva , CH 12, Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne , CH 10, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

12

Study ID:

NCT00021242

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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