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Home > "C" Clinical Trials Conditions > Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia  Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
For Condition: Myeloid Leukemia
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated.
Details: OBJECTIVES: - Determine the efficacy of cytarabine and daunorubicin as induction chemotherapy in older patients with previously untreated non-M3 acute myeloid leukemia. - Determine the frequency and severity of toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising daunorubicin IV continuously over days 1-3 and cytarabine IV continuously over days 1-7. Patients may be treated with a second course of induction chemotherapy beginning on day 19 if remission is not achieved at that time. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 15 and continuing until blood counts recover. Patients who achieve remission after the first or second course of induction chemotherapy receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2 and cytarabine IV continuously over days 1-5. Beginning no earlier than day 19, patients receive a second course of consolidation chemotherapy. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: Approximately 30-55 patients will be accrued for this study within 8-9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 56 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed acute myeloid leukemia (AML) - No M3 AML or blastic transformation of chronic myelogenous leukemia - Must be enrolled on SWOG-9007 and S9910 protocols PATIENT CHARACTERISTICS: Age: - 56 and over Performance status: - Zubrod 0-3 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT or SGPT no greater than 4 times ULN Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance greater than 40 mL/min Cardiovascular: - LVEF at least 50% by MUGA scan or 2-dimensional echocardiogram - No unstable cardiac arrhythmias - No unstable angina Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior systemic chemotherapy for acute leukemia - Prior hydroxyurea to control high cell counts allowed - Prior low-dose cytarabine (less than 100 mg/m^2/day) for treatment of myelodysplastic syndrome allowed - At least 30 days since prior chemotherapy and recovered - Concurrent single-dose intrathecal chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasChauncey, Study Chair, University of Washington
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
University of Washington School of Medicine
Seattle, Washington, 98195
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
Additional Information:
Study ID Numbers: CDR0000068861; SWOG-S0112
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023777
Other Myeloid Leukemia Studies:
1. Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
3. Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
4. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
5. Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
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Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
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