Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
NCT ID: NCT00006045
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
2000-03-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over) and duration of previous complete remission (CR) (0-6 vs 7-12 months). All patients receive induction chemotherapy comprised of cytarabine IV over 2 hours, mitoxantrone IV over a maximum of 20 minutes, and etoposide IV over 1-2 hours on days 1-6. On day 5 of induction, patients are randomized to one of two treatment arms: Arm I: Patients receive day 6 of induction chemotherapy. Patients then receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 6-9 or 7-10. Treatment with MOAB HuM195 repeats every 2 weeks for 2 courses (courses 1 and 2) in the absence of disease progression or unacceptable toxicity. During course 1, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Patients who do not achieve CR by day 70 of induction and show evidence of bone marrow progression (regimen failure (RF)) are taken off study. Patients without RF are assigned to one of two consolidation groups based on response: Group A (CR): Patients receive consolidation chemotherapy comprised of mitoxantrone IV over a maximum of 20 minutes on days 1 and 2, and cytarabine IV over 2 hours and etoposide IV over 1-2 hours on days 1-4. Patients with New York Heart Association class II heart disease preconsolidation receive no mitoxantrone during consolidation. Patients receive MOAB HuM195 IV over 4 hours on days 4-7 or 5-8. Treatment with MOAB HuM195 repeats every 2 weeks for 2 additional courses (courses 3 and 4). During course 3, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Group B (partial remission (PR), hematologic improvement (HI), or stable disease (SD)): Patients receive MOAB HuM195 as in group A but no consolidation chemotherapy. Patients without RF after treatment on group A or B receive maintenance MOAB HuM195 IV over 4 hours on days 1-4. Treatment repeats every month for 8 additional courses (courses 5-12). Arm II: Patients receive day 6 of induction chemotherapy. Patients receive no MOAB HuM195 during the entire study. Patients without RF at day 70 of induction are assigned to one of two consolidation groups based on response: Group C (CR): Patients receive consolidation chemotherapy as in group A. Group D (PR, HI, or SD): Patients receive no further treatment. Patients may be eligible to receive MOAB HuM195 on PDL Study 195-302. Patients are followed every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 200 patients (100 per arm) will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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lintuzumab
cytarabine
etoposide
mitoxantrone hydrochloride
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration) SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) Renal: Creatinine less than 2.0 mg/dL (unless related to AML) Cardiovascular: Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study HIV negative No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation Chemotherapy: See Disease Characteristics For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Facet Biotech
INDUSTRY
Principal Investigators
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Daniel Levitt, MD, PhD
Role: STUDY_CHAIR
Facet Biotech
Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Beckman Research Institute, City of Hope
Los Angeles, California, United States
St. Joseph Hospital - Orange
Orange, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Sidney Kimmel Cancer Center
San Diego, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Emory Clinic
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Louisiana State University School of Medicine
Shreveport, Louisiana, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, United States
Washington University Barnard Cancer Center
St Louis, Missouri, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
West Clinic, P.C.
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Algemeen Ziekenhuis Middelheim
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Universitaetsklinikum Benjamin Franklin
Berlin, , Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, , Germany
Westfaelische Wilhelms-Universitaet
Münster, , Germany
University of Rostock
Rostock, , Germany
Academisch Medisch Centrum
Amsterdam, , Netherlands
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom
Royal Free Hospital
Hampstead, London, England, United Kingdom
Leeds Teaching Hospital Trust
Leeds, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Countries
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Other Identifiers
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PDL-195-301
Identifier Type: -
Identifier Source: secondary_id
MSKCC-00029
Identifier Type: -
Identifier Source: secondary_id
UCLA-9910050
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1819
Identifier Type: -
Identifier Source: secondary_id
CDR0000068061
Identifier Type: -
Identifier Source: org_study_id