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

March 5, 2015 updated by: Southwest Oncology Group

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CR
Time Frame: After induction therapy is completed
After induction therapy is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John E. Godwin, MD, MS, Loyola University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S0117 (Other Identifier: SWOG)
  • U10CA032102 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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