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
56 Years
N/A
Both
Leukemia
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete remission (CR)
Outcome Time Frame:
After induction therapy is completed
Safety Issue:
No
Principal Investigator
Thomas R. Chauncey, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Veterans Affairs
Authority:
United States: Federal Government
Study ID:
CDR0000318831
NCT ID:
NCT00066794
Start Date:
July 2004
Completion Date:
January 2010
Related Keywords:
- Leukemia
- adult acute monocytic leukemia (M5b)
- adult acute megakaryoblastic leukemia (M7)
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
- adult acute monoblastic leukemia (M5a)
- untreated adult acute myeloid leukemia
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult pure erythroid leukemia (M6b)
- adult erythroleukemia (M6a)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Tod Children's Hospital - Forum Health | Youngstown, Ohio 44501 |
| Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
| Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| Metropolitan Hospital | Grand Rapids, Michigan 49506 |
| Holland Community Hospital | Holland, Michigan 49423 |
| Hackley Hospital | Muskegon, Michigan 49443 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
| David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Medical Oncology | Kalispell, Montana 59901 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grant Riverside Cancer Services | Columbus, Ohio 43215 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Stormont-Vail Cancer Center | Topeka, Kansas 66604 |
| St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
| Louisiana State University Health Sciences Center - Monroe | Monroe, Louisiana 71210 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
| Bay Regional Medical Center | Bay City, Michigan 48708 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
| Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
| Highland Hospital of Rochester | Rochester, New York 14620 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Mercy Medical Center | Springfield, Ohio 45504 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| Tulane Cancer Center | New Orleans, Louisiana 70112 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| AnMed Health Cancer Center | Anderson, South Carolina 29621 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
| Clinic of Dr. Judy L. Schmidt | Missoula, Montana 59804 |
| Mercy Regional Cancer Center at Mercy Medical Center | Redding, California 96049 |
