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LeukemiaPhase 2NCT00049179

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

A Phase 2 study testing cytarabine and gemtuzumab ozogamicin in people with Leukemia, run by SWOG Cancer Research Network at 151 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
cytarabine and gemtuzumab ozogamicin
Type of treatment
Injection or infusion
How many people
33 participants
Where
151 sitesUnited States
Study dates
Apr 2003to Oct 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

151 sites in 1 country.

151 sites in 1 country

United States151 sites

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31703

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Baton Rouge General Regional Cancer Center

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94705

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine Associates of Bozeman

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Mills-Peninsula Health Services

    Burlingame, California, 94010

  • St. James Community Hospital

    Butte, Montana, 59701

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233

  • Adena Regional Medical Center

    Chillicothe, Ohio, 54601

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital

    Eden, North Carolina, 27288

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Legacy Mount Hood Medical Center

    Glesham, Oregon, 97030

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27401

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Hematology Oncology Associates of Eastern Idaho

    Idaho Falls, Idaho, 83404

  • Community Oncology Group - Independence

    Independence, Ohio, 44131

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Orange Regional Medical Center - Horton Campus

    Middletown, New York, 10940

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59802

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59802

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Cancer Care Center at Skagit Valley Hospital

    Mount Vernon, Washington, 98273

  • Cancer Center at Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Institute of Oncology at Vilnius University

    Portland, Oregon, 97227

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67042

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78209

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • University Hospital - San Antonio

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29304

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Mercy Medical Center Oncology Unit

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Cancer Center at Stormont-Vail Regional Health Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Cancer Center at Southwest Washington Medical Center

    Vancouver, Washington, 98668

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Central Washington Hospital

    Wenatchee, Washington, 98801

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

    Westerville, Ohio, 43081

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A.

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Tod Children's Hospital - Forum Health

    Youngstown, Ohio, 44501

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Leukemia
Being tested
cytarabine, gemtuzumab ozogamicin
Keywords
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
Medical subject headings
Leukemia, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cytarabineDrug

    ind and consol: 200 mg/m2/d continuous IV days 1-7

  • gemtuzumab ozogamicinDrug

    ind and consol: 6 mg/m2 IV over 2 hrs day 1, 4mg/m2 IV over 2 hrs day 8

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CR

    Measured: After induction therapy is completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionDec 2005
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049179
Sponsor's protocol ID
S0117
Other IDs
S0117, U10CA032102
Status last verified
Mar 2015
First submitted
12 Nov 2002
Last updated
6 Mar 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cytarabine and gemtuzumab ozogamicin in people with Leukemia, run by SWOG Cancer Research Network at 151 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR (time frame: After induction therapy is completed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049179.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

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