A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Leukemia
Both
Leukemia
Trial Information
A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
OBJECTIVES:
- Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients
with relapsed acute myeloid leukemia.
- Determine the frequency and severity of toxic effects of this regimen in CD33-positive
patients.
- Determine, preliminarily, the prognostic significance of drug resistance phenotype,
cytogenetics, and molecular genetic characteristics of patients treated with this
regimen.
OUTLINE: This is a multicenter study.
- Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1
and 8 and cytarabine IV continuously over days 1-7.
- Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow,
B1 peripheral blood, and C1 extramedullary disease status receive one course of
gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.
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 30-55 patients will be accrued for this study within 10-28
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia (AML)
- FAB M1-2 or M4-7
- No blastic transformation of chronic myelogenous leukemia
- In first relapse after prior complete response
- Patients who relapsed after autologous or allogeneic bone marrow or peripheral
blood stem cell transplantation are not eligible
- CD33 positive
- Prior myelodysplastic syndromes or secondary AML allowed
- Concurrent enrollment on SWOG-9007 (cytogenetics protocol)
- No clinical or documented CNS involvement with AML
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC no greater than 30,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 1.5 times ULN
Renal
- Not specified
Cardiovascular
- No unstable cardiac arrhythmias
- No unstable angina
Other
- HIV negative
- No other malignancy within the past 5 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Adequately treated stage I or II cancer currently in complete remission
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior gemtuzumab ozogamicin for AML
Chemotherapy
- Prior hydroxyurea to control high cell counts allowed
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 4 weeks since prior investigational agents and recovered
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
CR
Outcome Time Frame:
After induction therapy is completed
Safety Issue:
No
Principal Investigator
John E. Godwin, MD, MS
Investigator Role:
Study Chair
Investigator Affiliation:
Loyola University
Authority:
United States: Federal Government
Study ID:
CDR0000257843
NCT ID:
NCT00049179
Start Date:
April 2003
Completion Date:
October 2010
Related Keywords:
- Leukemia
- adult acute monocytic leukemia (M5b)
- adult acute erythroid leukemia (M6)
- adult acute megakaryoblastic leukemia (M7)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
- adult acute monoblastic leukemia (M5a)
- recurrent adult acute myeloid leukemia
- secondary 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
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Tod Children's Hospital - Forum Health | Youngstown, Ohio 44501 |
| 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 |
| Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
| Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
| Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
| Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
| Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, P.A. | Wichita, Kansas 67208 |
| Associates in Womens Health | Wichita, Kansas 67203 |
| Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
| Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
| St. Francis Medical Center | Cape Girardeau, Missouri 63701 |
| 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 |
| Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
| Internal Medicine Associates of Bozeman | Bozeman, Montana 59715 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| Sletten Regional Cancer Institute | 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 |
| Eastern Montana Cancer Center | Miles City, Montana 59301 |
| 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 |
| Mount Carmel West Hospital | Columbus, Ohio 43222 |
| 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 |
| Mercy Medical Center Oncology Unit | Springfield, Ohio 45504 |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Central Washington Hospital | Wenatchee, Washington 98801 |
| Wenatchee Valley Clinic | Wenatchee, Washington 98801 |
| Welch Cancer Center | Sheridan, Wyoming 82801 |
| Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
| 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 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
| California Pacific Medical Center - California Campus | San Francisco, California 94118 |
| Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
| Piedmont Hospital | Atlanta, Georgia 30309 |
| WellStar Cobb Hospital | Austell, Georgia 30106 |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
| Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
| Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
| Salina Regional Health Center | Salina, Kansas 67401 |
| St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
| Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
| Louisiana State University Health Sciences Center - Monroe | Monroe, Louisiana 71210 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
| Cancer Therapy and Research Center | San Antonio, Texas 78229 |
| University Hospital - San Antonio | San Antonio, Texas 78229 |
| Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
| Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70140-1015 |
| Community Oncology Group - Independence | Independence, Ohio 44131 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| Mills-Peninsula Health Services | Burlingame, California 94010 |
| St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
| Tulane Cancer Center | New Orleans, Louisiana 70112 |
| Randolph Hospital | Asheboro, North Carolina 27203 |
| John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden, North Carolina 27288 |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
| Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
| Miami Valley Hospital | Dayton, Ohio 45409 |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland, Oregon 97210 |
| Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
| Cancer Care Center at Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
| Cancer Center at Southwest Washington Medical Center | Vancouver, Washington 98668 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Phoebe Cancer Center at Phoebe Putney Memorial Hospital | Albany, Georgia 31702 |
| Hematology Oncology Associates of Eastern Idaho | Idaho Falls, Idaho 83404 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Orange Regional Medical Center - Horton Campus | Middletown, New York 10940-4199 |
| Cancer Center at Stormont-Vail Regional Health Center | Topeka, Kansas 66604 |
