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Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
This study is ongoing, but not recruiting participants.
First Received: November 12, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049179
  Purpose

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.


Condition Intervention Phase
Leukemia
 Drug: cytarabine
Drug: gemtuzumab ozogamicin
 Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Cytarabine hydrochloride Gemtuzumab ozogamicin Cytarabine
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and efficacy [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics [ Designated as safety issue: No ]

Study Start Date: April 2003
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049179

  Hide Study Locations
Locations
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94705
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States, 94904
Mills-Peninsula Health Services
Burlingame, California, United States, 94010
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31703
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
United States, Idaho
Hematology Oncology Associates of Eastern Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
United States, Indiana
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
United States, Kansas
Associates in Womens Health
Wichita, Kansas, United States, 67203
Cancer Center at Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States, 67068
CCOP - Wichita
Wichita, Kansas, United States, 67214
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Pratt Cancer Center of Kansas
Pratt, Kansas, United States, 67124
Salina Regional Health Center
Salina, Kansas, United States, 67401
Southwest Medical Center
Liberal, Kansas, United States, 67901
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States, 70806
Cancer Center at Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States, 71210
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71101
United States, Michigan
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
St. Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
St. Francis Medical Center
Cape Girardeau, Missouri, United States, 63701
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59101
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls Clinic
Great Falls, Montana, United States, 59405
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States, 59715
Community Medical Center
Missoula, Montana, United States, 59801
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59802
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59802
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Sletten Regional Cancer Institute
Great Falls, Montana, United States, 59405
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Orange Regional Medical Center - Horton Campus
Middletown, New York, United States, 10940
United States, North Carolina
Annie Penn Cancer Center
Reidsville, North Carolina, United States, 27320
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, United States, 27288
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27401
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233
United States, Ohio
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Adena Regional Medical Center
Chillicothe, Ohio, United States, 54601
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Community Oncology Group - Independence
Independence, Ohio, United States, 44131
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grandview Hospital
Dayton, Ohio, United States, 45405
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Mercy Medical Center Oncology Unit
Springfield, Ohio, United States, 45504
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
CCOP - Columbus
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
Portland, Oregon, United States, 97210
Institute of Oncology at Vilnius University
Portland, Oregon, United States, 97227
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Legacy Mount Hood Medical Center
Glesham, Oregon, United States, 97030
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29304
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Cancer Care Center at Skagit Valley Hospital
Mt. Vernon, Washington, United States, 98273
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Cancer Center at Southwest Washington Medical Center
Vancouver, Washington, United States, 98668
Central Washington Hospital
Wenatchee, Washington, United States, 98801
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
United States, Wyoming
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: John E. Godwin, MD, MS Loyola University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000257843, SWOG-S0117
Study First Received: November 12, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00049179     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid
Leukemia, Myeloid, Acute
 Gemtuzumab
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Antibodies, Monoclonal
Leukemia
Neoplasms
Therapeutic Uses
Cytarabine

ClinicalTrials.gov processed this record on November 27, 2009



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