Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066794

Purpose

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.

Condition	Intervention	Phase
Leukemia	Biological: filgrastim Biological: sargramostim Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Cyclosporine Cyclosporin Filgrastim Sargramostim Cytarabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease status [ Designated as safety issue: No ]
Complete remission (CR) [ Designated as safety issue: No ]
Treatment failure [ Designated as safety issue: No ]
Relapse from CR [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Performance status [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	July 2004

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.

Eligibility

Ages Eligible for Study:	56 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066794

Hide Study Locations

Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Mercy Regional Cancer Center at Mercy Medical Center
Redding, California, United States, 96049
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
United States, Illinois
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Stormont-Vail Cancer Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States, 71210
Tulane Cancer Center
Alexandria, Louisiana, United States, 71315-3198
United States, Michigan
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Hackley Hospital
Muskegon, Michigan, United States, 49443
Holland Community Hospital
Holland, Michigan, United States, 49423
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Metropolitan Hospital
Grand Rapids, Michigan, United States, 49506
Munson Medical Center
Traverse City, Michigan, United States, 49684
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States, 49503
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63701
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Clinic of Dr. Judy L. Schmidt
Missoula, Montana, United States, 59804
Community Medical Center
Missoula, Montana, United States, 59801
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, New York
Highland Hospital of Rochester
Rochester, New York, United States, 14620
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Mercy Medical Center
Springfield, Ohio, United States, 45504
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Group Health Central Hospital
Seattle, Washington, United States, 98112
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:	Thomas R. Chauncey, MD, PhD	Veterans Affairs Medical Center - Seattle
Investigator:	Cheryl L. Willman, MD	University of New Mexico
Investigator:	Marilyn L. Slovak, PhD	Beckman Research Institute

Study ID Numbers:	CDR0000318831, SWOG-S0301
Study First Received:	August 6, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00066794 History of Changes
Health Authority:	United States: Federal Government