Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia
- Registration Number
- NCT00112554
- Lead Sponsor
- Vion Pharmaceuticals
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.
- Detailed Description
OBJECTIVES:
Primary
* Compare the complete response (CR) and CR (with platelet count \< 100,000/mm\^3 but ≥ 20,000/mm\^3 \[transfusion independent for ≥ 7 consecutive days\]) (CRp) rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M.
Secondary
* Compare time to progression in patients treated with these regimens.
* Compare duration of response in patients treated with these regimens.
* Compare the survival of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. Patients are stratified according to age (\< 60 years vs ≥ 60 years) and duration of first complete response (CR) or CR (with platelet count \< 100,000/mm³ but ≥ 20,000/mm³ \[transfusion independent for ≥ 7 consecutive days\]) (CRp) (\< 12 months vs ≥ 12 months).
* Induction therapy: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
* Arm II: Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
In both arms, patients demonstrating at least 20% reduction of blasts in bone marrow (based on total cellularity and percent blasts) after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy.
* Consolidation therapy: Beginning 6 weeks after initial documentation of CR or CRp, patients receive 1 course of consolidation therapy, as per induction therapy, according to their randomized treatment arm. These patients may then proceed to other consolidation, maintenance, and/or intensification therapy (including stem cell transplantation) off study at the discretion of the physician.
After completion of study treatment, patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 420 patients (280 in arm I and 140 in arm II) will be accrued for this study within 24-30 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Induction therapy arm II placebo Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine). Induction therapy arm I cytarabine Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine). Induction therapy arm II cytarabine Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine). Induction therapy arm I laromustine Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method Time to tumor progression Duration of response Overall response Toxicity
Trial Locations
- Locations (62)
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
American Health Network - North Meridian
🇺🇸Indianapolis, Indiana, United States
Evaggelismos Hospital
🇬🇷Athens, Greece
Medical University of Lodz
🇵🇱Lodz, Poland
Centrum Onkologii Ziemi Lubelskiez
🇵🇱Lublin, Poland
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Medical University of Gdansk
🇵🇱Gdansk, Poland
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
University of Patras Medical School
🇬🇷Rio Patras, Greece
King's College Hospital
🇬🇧London, England, United Kingdom
Clinical Centre of Serbia
🇷🇸Belgrade, Serbia
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, England, United Kingdom
CHR Hotel Dieu
🇫🇷Nantes, France
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Universitaetsfrauenklinik Frankfurt
🇩🇪Frankfurt, Germany
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Institute of Haematology and Blood Transfusion
🇵🇱Warsaw, Poland
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Hopital Haut Leveque
🇫🇷Pessac, France
Wojskowy Instytut Medyczny
🇵🇱Warsaw, Poland
Clinic Centre Novi Sad
🇷🇸Novi Sad, Serbia
University Wurzburg
🇩🇪Wurzburg, Germany
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Clinical Centre Nis
🇷🇸Nis, Serbia
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Brody School of Medicine at East Carolina University
🇺🇸Greenville, North Carolina, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
CHU Charleroi - Site Vesale
🇧🇪Montigny-le-Tilleul, Belgium
Capital District Health Authority Center for Clinical Research
🇨🇦Halifax, Nova Scotia, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
New Mexico Cancer Care Alliance
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Hopital Edouard Herriot
🇫🇷Lyon, France
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Manchester Royal Infirmary
🇬🇧Manchester, England, United Kingdom
Vancouver Hospital and Health Science Center
🇨🇦Vancouver, British Columbia, Canada
New York Medical College
🇺🇸Valhalla, New York, United States
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Memorial University of Newfoundland
🇨🇦St. John's, Newfoundland and Labrador, Canada