Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline

Completed

Started Apr 2003

Typical duration for phase_2 leukemia

Geographic Reach

1 country

151 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.5 years study duration

First Submitted

Initial submission to the registry

November 12, 2002

Completed

3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

2 months until next milestone

Study Start

First participant enrolled

April 1, 2003

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed

4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed

Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

November 12, 2002

Last Update Submit

March 5, 2015

Conditions

Leukemia

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 leukemiasecondary acute myeloid leukemiaadult 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

Outcome Measures

Primary Outcomes (1)

CR
After induction therapy is completed

Interventions

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (151)

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94705, United States

Location

Mills-Peninsula Health Services

Burlingame, California, 94010, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

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

Orange, California, 92868, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

Albany, Georgia, 31703, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Location

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

Savannah, Georgia, 31403, United States

Location

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, 83404, United States

Location

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

Alton, Illinois, 62002, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

St. Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

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

El Dorado, Kansas, 67042, United States

Location

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

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67042, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center at Stormont-Vail Regional Health Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Baton Rouge General Regional Cancer Center

Baton Rouge, Louisiana, 70806, United States

Location

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Louisiana State University Health Sciences Center - Monroe

Monroe, Louisiana, 71210, United States

Location

Cancer Center at Medical Center of Louisiana - New Orleans

New Orleans, Louisiana, 70112, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71101, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

St. Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

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

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium