Acute Myeloid Leukemia Clinical Trial
Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia.
Full Description
OBJECTIVES:
Determine the complete response rate in children with primary refractory or recurrent acute myeloid leukemia (AML) or secondary AML treated with idarubicin and cladribine. (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)
Compare the remission reinduction rates in children who relapse at 1 year or earlier vs more than 1 year from time of initial remission.
Determine the toxic effects of this regimen in this patient population.
OUTLINE: Patients are stratified according to disease characteristics (primary or secondary acute myeloid leukemia (AML) with first untreated relapse vs primary refractory AML). (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)
Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 51-102 patients will be accrued for this study within 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Acute myeloid leukemia (AML) (FAB M0-M7)
Secondary AML in first relapse (Secondary AML stratum closed as of 04/02/02)
AML in primary induction failure (Refractory AML stratum closed as of 04/03/01)
Myelodysplastic syndromes (MDS) (not related to Down syndrome) (MDS stratum closed as of 04/03/01)
Extramedullary disease allowed
Relapse more than 6 months after allogeneic or autologous bone marrow transplantation allowed
PATIENT CHARACTERISTICS:
Age:
Under 21 at diagnosis
Performance status:
Karnofsky 50-100% (over 10 years)
Lansky 50-100% (10 years and under)
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Bilirubin less than 1.5 mg/dL
ALT less than 3 times normal
Renal:
Creatinine less than 2 times normal
Cardiovascular:
Shortening fraction greater than 29%
Ejection fraction greater than 55% with normal wall motion
Other:
No uncontrolled infection
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
Chemotherapy:
At least 12 weeks since prior idarubicin and recovered
At least 2 weeks since other prior chemotherapy and recovered
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 224 Locations for this study
Birmingham Alabama, 35233, United States
Mobile Alabama, 36604, United States
Phoenix Arizona, 85016, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Downey California, 90242, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Loma Linda California, 92354, United States
Long Beach California, 90801, United States
Los Angeles California, 90027, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Madera California, 93638, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
Sacramento California, 95816, United States
Sacramento California, 95817, United States
San Diego California, 92120, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
San Francisco California, 94143, United States
Santa Barbara California, 93102, United States
Santa Clara California, 95051, United States
Travis Air Force Base California, 94535, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Farmington Connecticut, 06360, United States
New Haven Connecticut, 06520, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20010, United States
Washington District of Columbia, 20307, United States
Fort Lauderdale Florida, 33316, United States
Fort Myers Florida, 33908, United States
Gainesville Florida, 32610, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
Miami Florida, 33155, United States
Miami Florida, 33176, United States
Orlando Florida, 32803, United States
Orlando Florida, 32806, United States
Pensacola Florida, 32504, United States
St. Petersburg Florida, 33701, United States
Tampa Florida, 33677, United States
West Palm Beach Florida, 33407, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Macon Georgia, 31201, United States
Savannah Georgia, 31403, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96859, United States
Boise Idaho, 83712, United States
Chicago Illinois, 60601, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60614, United States
Oak Lawn Illinois, 60453, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61637, United States
Springfield Illinois, 62794, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
Des Moines Iowa, 50308, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70118, United States
New Orleans Louisiana, 70121, United States
Bangor Maine, 04401, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21225, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02115, United States
Springfield Massachusetts, 01107, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Detroit Michigan, 48236, United States
East Lansing Michigan, 48824, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Royal Oak Michigan, 48073, United States
Royal Oak Michigan, 48073, United States
Duluth Minnesota, 55805, United States
Minneapolis Minnesota, 55404, United States
Rochester Minnesota, 55905, United States
Saint Paul Minnesota, 55102, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64108, United States
Saint Louis Missouri, 63104, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89109, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08903, United States
Newark New Jersey, 07112, United States
Paterson New Jersey, 07503, United States
Summit New Jersey, 07901, United States
Albuquerque New Mexico, 87131, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Brooklyn New York, 11201, United States
Brooklyn New York, 11203, United States
Brooklyn New York, 11212, United States
Brooklyn New York, 11219, United States
Buffalo New York, 14263, United States
Manhasset New York, 11030, United States
New Hyde Park New York, 11042, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10029, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Stony Brook New York, 11790, United States
Syracuse New York, 13210, United States
Valhalla New York, 10595, United States
Asheville North Carolina, 28801, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28232, United States
Charlotte North Carolina, 28233, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27157, United States
Fargo North Dakota, 58103, United States
Akron Ohio, 44308, United States
Cincinnati Ohio, 45229, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43205, United States
Dayton Ohio, 45404, United States
Toledo Ohio, 43601, United States
Toledo Ohio, 43608, United States
Youngstown Ohio, 44501, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74136, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97201, United States
Portland Oregon, 97227, United States
Danville Pennsylvania, 17822, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19134, United States
Pittsburgh Pennsylvania, 15213, United States
Providence Rhode Island, 02818, United States
Charleston South Carolina, 29425, United States
Columbia South Carolina, 29203, United States
Greenville South Carolina, 29605, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Johnson City Tennessee, 37604, United States
Knoxville Tennessee, 37901, United States
Memphis Tennessee, 38105, United States
Nashville Tennessee, 37232, United States
Amarillo Texas, 79106, United States
Austin Texas, 78701, United States
Dallas Texas, 75230, United States
Dallas Texas, 75235, United States
Fort Worth Texas, 76104, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Lackland Air Force Base Texas, 78236, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78207, United States
San Antonio Texas, 78229, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Falls Church Virginia, 22042, United States
Norfolk Virginia, 23507, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24013, United States
Seattle Washington, 98105, United States
Seattle Washington, 98109, United States
Seattle Washington, 98112, United States
Spokane Washington, 99210, United States
Tacoma Washington, 98415, United States
Tacoma Washington, 98431, United States
Charleston West Virginia, 25302, United States
Huntington West Virginia, 25701, United States
Morgantown West Virginia, 26506, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Randwick New South Wales, 2031, Australia
Westmead New South Wales, 2145, Australia
Brisbane Queensland, 4029, Australia
North Adelaide South Australia, 5006, Australia
Parkville Victoria, 3052, Australia
Perth Western Australia, 6001, Australia
Calgary Alberta, T2T 5, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V6H 3, Canada
Winnipeg Manitoba, R3E 0, Canada
St. John's Newfoundland and Labrador, A1B 3, Canada
Halifax Nova Scotia, B3J 3, Canada
Hamilton Ontario, L8N 3, Canada
London Ontario, N6C 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3H 1, Canada
Montreal Quebec, H3T 1, Canada
Sainte Foy Quebec, GIV 4, Canada
Sainte-Foy Quebec, G1V 4, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Groningen , 9700 , Netherlands
Auckland , , New Zealand
San Juan , 00936, Puerto Rico
Santurce , 00912, Puerto Rico
Bern , CH 30, Switzerland
Geneva , CH 12, Switzerland
Lausanne , CH 10, Switzerland
How clear is this clinincal trial information?