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Home > "C" Clinical Trials Conditions > Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia



Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

For Condition: adult acute myeloid leukemia,adult acute monocytic leukemia
Status: Suspended
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine, 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 combing cyclosporine with daunorubicin and cytarabine in treating older patients who have untreated acute myeloid leukemia.
Details: OBJECTIVES: - Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in patients age 56 and over with previously untreated acute myeloid leukemia. - Determine the frequency and severity of toxic effects of this regimen in these patients. - Determine, preliminarily, the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen. - Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these patients. OUTLINE: This is a multicenter study. - Induction:Patients receive cyclosporine IV and daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7. Patients who achieve complete response (CR) after chemotherapy receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover. Patients who maintain CR after 2 courses of induction therapy proceed to consolidation phase. - Consolidation:Patients receive treatment as in induction with cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5. Patients achieving CR receive an additional course of chemotherapy beginning at least 14 days after completion of the first course of cytarabine. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years thereafter. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 13 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 56 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Morphologically confirmed acute myeloid leukemia (AML) - Differential diagnosis of AML based on FAB classification system - M0-M7 (No M3) - No blastic transformation of chronic myelogenous leukemia - Must be currently registered on protocols SWOG-9007 and SWOG-S9910 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) - AST and/or ALT no greater than 4 times ULN Renal - Creatinine no greater than 1.5 times ULN AND/OR - Creatinine clearance greater than 40 mL/min Cardiovascular - Left ventricular function normal - Ejection fraction at least 50% by MUGA or echocardiogram - No unstable cardiac arrhythmias - No unstable angina Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent pegfilgrastim Chemotherapy - At least 30 days since prior low-dose cytarabine (less than 100 mg/m^2/day) for myelodysplastic syndromes and recovered - Prior hydroxyurea to control high cell counts allowed - No prior systemic chemotherapy for acute leukemia - 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:
AlanList,  ,  Arizona Cancer Center

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

MBCCOP - LSU Health Sciences Center
New Orleans,  Louisiana,  70112
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201-1379
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Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago,  Illinois,  60612
United States
 

Veterans Affairs Medical Center - Houston
Houston,  Texas,  77030
United States
 

Veterans Affairs Medical Center - Ann Arbor
Ann Arbor,  Michigan,  48105
United States
 

CCOP - Atlanta Regional
Atlanta,  Georgia,  30342-1701
United States
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4095
United States
 

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles,  California,  90033
United States
 

Danville Radiation Therapy Center
Memphis,  Tennessee,  38104
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington,  Kentucky,  40536-0084
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

Veterans Affairs Medical Center - Albuquerque
Albuquerque,  New Mexico,  87108-5138
United States
 

University of Michigan Comprehensive Cancer Center
Ann Arbor,  Michigan,  48109-0912
United States
 

CCOP - Beaumont
Royal Oak,  Michigan,  48073-6769
United States
 

CCOP - Santa Rosa Memorial Hospital
Santa Rosa,  California,  95403
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines,  Illinois,  60141
United States
 

CCOP - Western Regional, Arizona
Phoenix,  Arizona,  85006-2726
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

Veterans Affairs Medical Center - Wichita
Wichita,  Kansas,  67218
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

Charles M. Barrett Cancer Center at University Hospital
Cincinnati,  Ohio,  45267-0501
United States
 

Veterans Affairs Medical Center - Albany
Albany,  New York,  12208
United States
 

CCOP - Northwest
Tacoma,  Washington,  98405-0986
United States
 

Louisiana State University Health Sciences Center - Shreveport
Shreveport,  Louisiana,  71130-3932
United States
 

Veterans Affairs Medical Center - Seattle
Seattle,  Washington,  98108
United States
 

James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

CCOP - Virginia Mason Research Center
Seattle,  Washington,  98101
United States
 

University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora,  Colorado,  80010
United States
 

Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City,  Kansas,  66160-7353
United States
 

Josephine Ford Cancer Center at Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

Veterans Affairs Medical Center - Charleston
Charleston,  South Carolina,  29401-5799
United States
 

Veterans Affairs Medical Center - Salt Lake City
Salt Lake City,  Utah,  84148
United States
 

MBCCOP - Howard University Cancer Center
Washington D.C.,  District of Columbia,  20060
United States
 

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City,  Oklahoma,  73104
United States
 

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix,  Arizona,  85012
United States
 

MBCCOP - Gulf Coast
Mobile,  Alabama,  36688
United States
 

David Grant Medical Center
Travis Air Force Base,  California,  94535
United States
 

Veterans Affairs Medical Center - Lexington
Lexington,  Kentucky,  40502-2236
United States
 

Veterans Affairs Medical Center - Biloxi
Biloxi,  Mississippi,  39531-2410
United States
 

Veterans Affairs Medical Center - Dayton
Dayton,  Ohio,  45428-1002
United States
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010-0269
United States
 

Hollings Cancer Center at Medical University of South Carolina
Charleston,  South Carolina,  29425
United States
 

Veterans Affairs Medical Center - Tucson
Tucson,  Arizona,  85723
United States
 

CCOP - St. Louis-Cape Girardeau
St. Louis,  Missouri,  63141
United States
 

Veterans Affairs Medical Center - Temple
Temple,  Texas,  76504
United States
 

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange,  California,  92868
United States
 

Veterans Affairs Medical Center - Kansas City
Kansas City,  Missouri,  64128
United States
 

Brooke Army Medical Center
Fort Sam Houston,  Texas,  78234-6200
United States
 

Veterans Affairs Medical Center - New Orleans
New Orleans,  Louisiana,  70112
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195-9001
United States
 

MBCCOP - Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

Veterans Affairs Medical Center - Amarillo
Amarillo,  Texas,  79106
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112-5550
United States
 

St. Louis University Hospital Cancer Center
St. Louis,  Missouri,  63110
United States
 

Madigan Army Medical Center
Tacoma,  Washington,  98431-5000
United States
 

Providence Cancer Institute at Providence Hospital
Southfield,  Michigan,  48075
United States
 

Harrington Cancer Center
Amarillo,  Texas,  79106
United States
 

Veterans Affairs Medical Center - Shreveport
Shreveport,  Louisiana,  71130
United States
 

Veterans Affairs Medical Center - Jackson
Jackson,  Mississippi,  39216
United States
 

MBCCOP - Hawaii
Honolulu,  Hawaii,  96813
United States
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

CCOP - Dayton
Dayton,  Ohio,  45429
United States
 

CCOP - Michigan Cancer Research Consortium
Ann Arbor,  Michigan,  48106
United States
 

Veterans Affairs Medical Center - Portland
Portland,  Oregon,  97207
United States
 

CCOP - Grand Rapids
Grand Rapids,  Michigan,  49503
United States
 

University of Tennessee Cancer Institute
Memphis,  Tennessee,  38103
United States
 

Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio,  Texas,  78229
United States
 

Veterans Affairs Outpatient Clinic - Martinez
Martinez,  California,  94553
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78229-3900
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

Herbert Irving Comprehensive Cancer Center at Columbia University
New York City,  New York,  10032
United States
 

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle,  Washington,  98104
United States
 

Cancer Institute at Oregon Health and Science University
Portland,  Oregon,  97201-3098
United States
 

MBCCOP - University of New Mexico HSC
Albuquerque,  New Mexico,  87131
United States
 

Veterans Affairs Medical Center - Detroit
Detroit,  Michigan,  48201-1932
United States
 

CCOP - Columbia River Oncology Program
Portland,  Oregon,  97225
United States
 

Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson,  Arizona,  85724
United States
 

CCOP - Bay Area Tumor Institute
Oakland,  California,  94609-3305
United States
 

Cancer Research Center of Hawaii
Honolulu,  Hawaii,  96813
United States
 

Cancer Research Center at Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

Tulane University School of Medicine
New Orleans,  Louisiana,  70112
United States
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0565
United States
 

Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood,  Illinois,  60153-5500
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Veterans Affairs Medical Center - Oklahoma City
Oklahoma City,  Oklahoma,  73104
United States
 

Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock,  Arkansas,  72205
United States
 

Veterans Affairs Medical Center - Cincinnati
Cincinnati,  Ohio,  45220-2288
United States
 

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 


Additional Information:
Study ID Numbers:
  CDR0000318831;  SWOG-S0301
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066794

Other Adult Acute Monocytic Leukemia Studies:
1. VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies

2. Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

3. Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia

4. Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia

5. Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

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