Acute Myeloid Leukemia Clinical Trial

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S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

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Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT00049179

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 123 Locations for this study

See Locations Near You

Alta Bates Comprehensive Cancer Center
Berkeley California, 94705, United States
Mills-Peninsula Health Services
Burlingame California, 94010, United States
Marin Cancer Institute at Marin General Hospital
Greenbrae California, 94904, United States
Sutter Health Western Division Cancer Research Group
Greenbrae California, 94904, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange California, 92868, United States
California Pacific Medical Center - California Campus
San Francisco California, 94118, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany Georgia, 31703, United States
Piedmont Hospital
Atlanta Georgia, 30309, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Northside Hospital Cancer Center
Atlanta Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta Georgia, 30342, United States
WellStar Cobb Hospital
Austell Georgia, 30106, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur Georgia, 30033, United States
Gwinnett Medical Center
Lawrenceville Georgia, 30045, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta Georgia, 30060, United States
Southern Regional Medical Center
Riverdale Georgia, 30274, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
Hematology Oncology Associates of Eastern Idaho
Idaho Falls Idaho, 83404, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton Illinois, 62002, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines
Hines Illinois, 60141, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
St. Francis Hospital and Health Centers
Beech Grove Indiana, 46107, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado Kansas, 67042, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons Kansas, 67357, United States
Pratt Cancer Center of Kansas
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67042, United States
Salina Regional Health Center
Salina Kansas, 67401, United States
Cancer Center at Stormont-Vail Regional Health Center
Topeka Kansas, 66604, United States
St. Francis Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health
Wichita Kansas, 67203, United States
Cancer Center of Kansas, P.A.
Wichita Kansas, 67208, United States
Cancer Center of Kansas, P.A. - 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 - Winfield
Winfield Kansas, 67156, United States
Baton Rouge General Regional Cancer Center
Baton Rouge Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge Louisiana, 70809, United States
Louisiana State University Health Sciences Center - Monroe
Monroe Louisiana, 71210, United States
Cancer Center at Medical Center of Louisiana - New Orleans
New Orleans Louisiana, 70112, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane Cancer Center
New Orleans Louisiana, 70112, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71101, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport Louisiana, 71130, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield Michigan, 48075, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
St. 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 - Kansas City
Kansas City Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, 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
Deaconess Billings Clinic - Downtown
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 Cancer Center
Billings Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Internal Medicine Associates of Bozeman
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
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
Eastern Montana Cancer Center
Miles City Montana, 59301, United States
Community Medical Center
Missoula Montana, 59801, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59802, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59802, United States
Orange Regional Medical Center - Horton Campus
Middletown New York, 10940, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden North Carolina, 27288, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro North Carolina, 27401, United States
Annie Penn Cancer Center
Reidsville North Carolina, 27320, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Adena Regional Medical Center
Chillicothe Ohio, 54601, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Riverside Cancer Services
Columbus Ohio, 43215, United States
Mount Carmel West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Community Oncology Group - Independence
Independence Ohio, 44131, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Mercy Medical Center Oncology Unit
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville Ohio, 43081, United States
Cleveland Clinic - Wooster
Wooster Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Tod Children's Hospital - Forum Health
Youngstown Ohio, 44501, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Legacy Mount Hood Medical Center
Glesham Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
Portland Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
CCOP - Columbia River Oncology Program
Portland Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Institute of Oncology at Vilnius University
Portland Oregon, 97227, United States
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson South Carolina, 29621, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29304, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78209, United States
Cancer Therapy and Research Center
San Antonio Texas, 78229, United States
University Hospital - San Antonio
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, 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
St. Joseph Hospital Community Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Cancer Care Center at Skagit Valley Hospital
Mt. Vernon Washington, 98273, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Group Health Central Hospital
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98114, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Cancer Center at Southwest Washington Medical Center
Vancouver Washington, 98668, United States
Central Washington Hospital
Wenatchee Washington, 98801, United States
Wenatchee Valley Clinic
Wenatchee Washington, 98801, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States
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How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT00049179

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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