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| ID | Type | Description | Link |
|---|---|---|---|
| S0301 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE: This is a multicenter study.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | 5 mcg/kg/d IV or SC starting apx day 15 | ||
| sargramostim | Biological | 250 mcg/kg/d IV or SC starting apx day 15 | ||
| cyclosporine | Drug | ind: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-74 consol: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-50 | ||
| cytarabine | Drug | ind: 200 mg/m2/d cont IV days 2-74 | ||
| daunorubicin hydrochloride | Drug | ind: 45 mg/m2/d cont IV days 2-74 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (CR) | After induction therapy is completed |
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DISEASE CHARACTERISTICS:
Morphologically confirmed acute myeloid leukemia (AML)
Differential diagnosis of AML based on FAB classification system
No blastic transformation of chronic myelogenous leukemia
Must be currently registered on protocols SWOG-9007 and SWOG-S9910
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R. Chauncey, MD, PhD | VA Puget Sound Health Care System | Principal Investigator |
| Cheryl L. Willman, MD | University of New Mexico Cancer Center | Principal Investigator |
| Marilyn L. Slovak, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Arizona Cancer Center at University of Arizona Health Sciences Center |
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| Tucson |
| Arizona |
| 85724-5024 |
| United States |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | 92868 | United States |
| Mercy Regional Cancer Center at Mercy Medical Center | Redding | California | 96049 | United States |
| St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho | 83712 | United States |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | 62002 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | United States |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| Stormont-Vail Cancer Center | Topeka | Kansas | 66604 | United States |
| St. Francis Comprehensive Cancer Center | Topeka | Kansas | 66606 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67203 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Tulane Cancer Center | Alexandria | Louisiana | 71315-3198 | United States |
| Louisiana State University Health Sciences Center - Monroe | Monroe | Louisiana | 71210 | United States |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana | 71130-3932 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Bay Regional Medical Center | Bay City | Michigan | 48708 | United States |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health Hospital - Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Metropolitan Hospital | Grand Rapids | Michigan | 49506 | United States |
| Holland Community Hospital | Holland | Michigan | 49423 | United States |
| Hackley Hospital | Muskegon | Michigan | 49443 | United States |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan | 48075 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63701 | United States |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau | Missouri | 63701 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| David C. Pratt Cancer Center at St. John's Mercy | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare | Billings | Montana | 59101 | United States |
| Deaconess Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| St. James Community Hospital | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Clinic of Dr. Judy L. Schmidt | Missoula | Montana | 59804 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Highland Hospital of Rochester | Rochester | New York | 14620 | United States |
| Interlakes Oncology/Hematology PC | Rochester | New York | 14623 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893-3428 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Riverside Cancer Services | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Mercy Medical Center | Springfield | Ohio | 45504 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville | Ohio | 43081 | United States |
| Tod Children's Hospital - Forum Health | Youngstown | Ohio | 44501 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D007948 | Leukemia, Monocytic, Acute |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D000013 | Congenital Abnormalities |
| D004915 | Leukemia, Erythroblastic, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| C081222 | sargramostim |
| D016572 | Cyclosporine |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
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