Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00006045
- Lead Sponsor
- Facet Biotech
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia.
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
OBJECTIVES: I. Compare the efficacy, safety, pharmacokinetics, and immunogenicity of mitoxantrone, etoposide, and cytarabine (MEC) with or without monoclonal antibody HuG1-M195 in patients with refractory or relapsed acute myelogenous leukemia.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Leeds Teaching Hospital Trust
🇬🇧Leeds, England, United Kingdom
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Royal Free Hospital
🇬🇧Hampstead, London, England, United Kingdom
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Emory Clinic
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
St. Joseph Hospital - Orange
🇺🇸Orange, California, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Louisiana State University School of Medicine
🇺🇸Shreveport, Louisiana, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
North Mississippi Hematology and Oncology Associates, Ltd.
🇺🇸Tupelo, Mississippi, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Addenbrooke's NHS Trust
🇬🇧Cambridge, England, United Kingdom
CHRU de Nancy - Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
Universitaetsklinikum Benjamin Franklin
🇩🇪Berlin, Germany
Westfaelische Wilhelms-Universitaet
🇩🇪Munster, Germany
Queen Elizabeth II Health Science Center
🇨🇦Halifax, Nova Scotia, Canada
Sidney Kimmel Cancer Center
🇺🇸San Diego, California, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
New York Medical College
🇺🇸Valhalla, New York, United States
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Washington University Barnard Cancer Center
🇺🇸Saint Louis, Missouri, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
West Clinic, P.C.
🇺🇸Memphis, Tennessee, United States
Institut Jules Bordet
🇧🇪Brussels, Belgium
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
🇩🇪Munich, Germany
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
University of Rostock
🇩🇪Rostock, Germany
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States