Spots Global Cancer Trial Database for S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
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Trial Identification
Brief Title: S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Official Title: A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
Study ID: NCT00066794
Conditions
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 56 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, United States
Mercy Regional Cancer Center at Mercy Medical Center, Redding, California, United States
St. Luke's Mountain States Tumor Institute - Boise, Boise, Idaho, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois, United States
Good Samaritan Regional Health Center, Mt. Vernon, Illinois, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States
Stormont-Vail Cancer Center, Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center, Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Tulane Cancer Center, Alexandria, Louisiana, United States
Louisiana State University Health Sciences Center - Monroe, Monroe, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Bay Regional Medical Center, Bay City, Michigan, United States
Mecosta County Medical Center, Big Rapids, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus, Grand Rapids, Michigan, United States
Metropolitan Hospital, Grand Rapids, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Hackley Hospital, Muskegon, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Gape Girardeau, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Clinic of Dr. Judy L. Schmidt, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Highland Hospital of Rochester, Rochester, New York, United States
Interlakes Oncology/Hematology PC, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Wilson Medical Center, Wilson, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Riverside Cancer Services, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville, Ohio, United States
Tod Children's Hospital - Forum Health, Youngstown, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
Group Health Central Hospital, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Thomas R. Chauncey, MD, PhD
Affiliation: VA Puget Sound Health Care System
Role: PRINCIPAL_INVESTIGATOR
Name: Cheryl L. Willman, MD
Affiliation: University of New Mexico Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Marilyn L. Slovak, PhD
Affiliation: City of Hope Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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