Leukemia Clinical Trial
Official title:
A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Verified date | March 2015 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | October 2010 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Phoebe Cancer Center at Phoebe Putney Memorial Hospital | Albany | Georgia |
United States | Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois |
United States | Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson | South Carolina |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Northside Hospital Cancer Center | Atlanta | Georgia |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia |
United States | WellStar Cobb Hospital | Austell | Georgia |
United States | Baton Rouge General Regional Cancer Center | Baton Rouge | Louisiana |
United States | Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana |
United States | St. Francis Hospital and Health Centers | Beech Grove | Indiana |
United States | St. Joseph Hospital Community Cancer Center | Bellingham | Washington |
United States | Alta Bates Comprehensive Cancer Center | Berkeley | California |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Deaconess Billings Clinic - Downtown | Billings | Montana |
United States | Deaconess Billings Clinic Cancer Center | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare | Billings | Montana |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Internal Medicine Associates of Bozeman | Bozeman | Montana |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | Mills-Peninsula Health Services | Burlingame | California |
United States | St. James Community Hospital | Butte | Montana |
United States | St. Francis Medical Center | Cape Girardeau | Missouri |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Riverside Cancer Services | Columbus | Ohio |
United States | Mount Carmel West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | CCOP - Dayton | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden | North Carolina |
United States | Cancer Center of Kansas, P.A. - El Dorado | El Dorado | Kansas |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau | Missouri |
United States | Legacy Mount Hood Medical Center | Glesham | Oregon |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Big Sky Oncology | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Sletten Regional Cancer Institute | Great Falls | Montana |
United States | Marin Cancer Institute at Marin General Hospital | Greenbrae | California |
United States | Sutter Health Western Division Cancer Research Group | Greenbrae | California |
United States | Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina |
United States | St. Peter's Hospital | Helena | Montana |
United States | Veterans Affairs Medical Center - Hines | Hines | Illinois |
United States | Hematology Oncology Associates of Eastern Idaho | Idaho Falls | Idaho |
United States | Community Oncology Group - Independence | Independence | Ohio |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Cancer Center of Kansas - Kingman | Kingman | Kansas |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Gwinnett Medical Center | Lawrenceville | Georgia |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Middletown Regional Hospital | Middletown | Ohio |
United States | Orange Regional Medical Center - Horton Campus | Middletown | New York |
United States | Eastern Montana Cancer Center | Miles City | Montana |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Community Medical Center | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Louisiana State University Health Sciences Center - Monroe | Monroe | Louisiana |
United States | Cancer Care Center at Skagit Valley Hospital | Mt. Vernon | Washington |
United States | Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane Cancer Center | New Orleans | Louisiana |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California |
United States | Cancer Center of Kansas, P.A. - Parsons | Parsons | Kansas |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland | Oregon |
United States | Institute of Oncology at Vilnius University | Portland | Oregon |
United States | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Pratt Cancer Center of Kansas | Pratt | Kansas |
United States | Annie Penn Cancer Center | Reidsville | North Carolina |
United States | Southern Regional Medical Center | Riverdale | Georgia |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | Salina Regional Health Center | Salina | Kansas |
United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
United States | Cancer Therapy and Research Center | San Antonio | Texas |
United States | University Hospital - San Antonio | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas |
United States | California Pacific Medical Center - California Campus | San Francisco | California |
United States | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana |
United States | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana |
United States | Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | Mercy Medical Center Oncology Unit | Springfield | Ohio |
United States | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | CCOP - St. Louis-Cape Girardeau | St. Louis | Missouri |
United States | David C. Pratt Cancer Center at St. John's Mercy | St. Louis | Missouri |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Cancer Center at Stormont-Vail Regional Health Center | Topeka | Kansas |
United States | St. Francis Comprehensive Cancer Center | Topeka | Kansas |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | Cancer Center at Southwest Washington Medical Center | Vancouver | Washington |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Central Washington Hospital | Wenatchee | Washington |
United States | Wenatchee Valley Clinic | Wenatchee | Washington |
United States | Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville | Ohio |
United States | Associates in Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas, P.A. | Wichita | Kansas |
United States | Cancer Center of Kansas, P.A. - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Cleveland Clinic - Wooster | Wooster | Ohio |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | Tod Children's Hospital - Forum Health | Youngstown | Ohio |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CR | After induction therapy is completed | No |
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