Acute Myeloid Leukemia Clinical Trial
S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Summary
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: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia.
Full Description
OBJECTIVES:
Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in older patients 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 therapy: 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 therapy.
Consolidation therapy: Patients receive treatment as in induction therapy 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.
PROJECTED ACCRUAL: A total of 25-64 patients will be accrued for this study within 13 months.
Eligibility 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 (for patients 56 to 60 years of age) OR
Zubrod 0-2 (for patients 61 to 70 years of age) OR
Zubrod 0-1 (for patients 71 years of age and over)
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction
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 that 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 78 Locations for this study
Mobile Alabama, 36652, United States
Tucson Arizona, 85724, United States
Orange California, 92868, United States
Redding California, 96049, United States
Boise Idaho, 83712, United States
Alton Illinois, 62002, United States
Mt. Vernon Illinois, 62864, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66604, United States
Topeka Kansas, 66606, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Alexandria Louisiana, 71315, United States
Monroe Louisiana, 71210, United States
Shreveport Louisiana, 71130, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49017, United States
Bay City Michigan, 48708, United States
Big Rapids Michigan, 49307, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49506, United States
Holland Michigan, 49423, United States
Muskegon Michigan, 49443, United States
Southfield Michigan, 48075, United States
Traverse City Michigan, 49684, United States
Jackson Mississippi, 39216, United States
Cape Girardeau Missouri, 63701, United States
Gape Girardeau Missouri, 63701, United States
Saint Louis Missouri, 63141, United States
St. Louis Missouri, 63141, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Rochester New York, 14620, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Rutherfordton North Carolina, 28139, United States
Wilson North Carolina, 27893, United States
Akron Ohio, 44307, United States
Chillicothe Ohio, 45601, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Lancaster Ohio, 43130, United States
Marietta Ohio, 45750, United States
Newark Ohio, 43055, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Westerville Ohio, 43081, United States
Youngstown Ohio, 44501, United States
Zanesville Ohio, 43701, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Spokane Washington, 99202, United States
Sheridan Wyoming, 82801, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.