Leukemia Clinical Trial
Official title:
A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse
Verified date | February 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 420 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed acute myeloid leukemia (AML) - Any WHO classification, excluding acute promyelocytic leukemia - At least 10% blasts by bone marrow aspirate and/or biopsy - In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but = 20,000/mm³ [transfusion independent for = 7 consecutive days]) (CRp) that lasted = 3 months but = 24 months after completion of the initial induction regimen - Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin = 1.5 times upper limit of normal (ULN) - AST = 3 times ULN - Chronic hepatitis allowed Renal - Creatinine = 2.0 mg/dL Cardiovascular - No myocardial infarction within the past 3 months - No uncontrolled arrhythmias - No uncontrolled congestive heart failure Pulmonary - No severe chronic obstructive pulmonary disease - No requirement for supplemental oxygen at rest Immunologic - No uncontrolled active infection - Infections that are controlled and under active treatment with antibiotics allowed - No evidence of invasive fungal infection by blood or tissue cultures Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies - No other severe medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 12 hours since prior hydroxyurea Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No prior treatment while in first relapse except hydroxyurea - No other concurrent standard or investigational treatment for AML - No concurrent disulfiram (Antabuse®) |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | U.Z. Gasthuisberg | Leuven | |
Belgium | CHU Charleroi - Site Vesale | Montigny-le-Tilleul | |
Canada | Capital District Health Authority Center for Clinical Research | Halifax | Nova Scotia |
Canada | Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Memorial University of Newfoundland | St. John's | Newfoundland and Labrador |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Vancouver Hospital and Health Science Center | Vancouver | British Columbia |
France | Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Besancon | |
France | Hopital Edouard Herriot | Lyon | |
France | Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | |
France | CHR Hotel Dieu | Nantes | |
France | Hopital Haut Leveque | Pessac | |
Germany | Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | |
Germany | Medizinische Universitaetsklinik I at the University of Cologne | Cologne | |
Germany | Universitaetsfrauenklinik Frankfurt | Frankfurt | |
Germany | Universitatsklinikum Heidelberg | Heidelberg | |
Germany | Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster | Muenster | |
Germany | Klinikum der Universitaet Muenchen - Grosshadern Campus | Munich | |
Germany | University Wurzburg | Wurzburg | |
Greece | Evaggelismos Hospital | Athens | |
Greece | University of Patras Medical School | Rio Patras | |
Netherlands | University Medical Center Groningen | Groningen | |
Poland | Medical University of Gdansk | Gdansk | |
Poland | Medical University of Lodz | Lodz | |
Poland | Centrum Onkologii Ziemi Lubelskiez | Lublin | |
Poland | Institute of Haematology and Blood Transfusion | Warsaw | |
Poland | Wojskowy Instytut Medyczny | Warsaw | |
Serbia | Clinical Centre of Serbia | Belgrade | |
Serbia | Clinical Centre Nis | Nis | |
Serbia | Clinic Centre Novi Sad | Novi Sad | |
United Kingdom | Birmingham Heartlands Hospital | Birmingham | England |
United Kingdom | Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England |
United Kingdom | University Hospital of Wales | Cardiff | Wales |
United Kingdom | Leicester Royal Infirmary | Leicester | England |
United Kingdom | King's College Hospital | London | England |
United Kingdom | Manchester Royal Infirmary | Manchester | England |
United States | New Mexico Cancer Care Alliance | Albuquerque | New Mexico |
United States | 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 | Roswell Park Cancer Institute | Buffalo | New York |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Brody School of Medicine at East Carolina University | Greenville | North Carolina |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | M.D. Anderson Cancer Center at University of Texas | Houston | Texas |
United States | American Health Network - North Meridian | Indianapolis | Indiana |
United States | Nevada Cancer Institute | Las Vegas | Nevada |
United States | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California |
United States | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
United States | Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida |
United States | New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
Vion Pharmaceuticals |
United States, Belgium, Canada, France, Germany, Greece, Netherlands, Poland, Serbia, United Kingdom,
Giles F, Vey N, DeAngelo D, Seiter K, Stock W, Stuart R, Boskovic D, Pigneux A, Tallman M, Brandwein J, Kell J, Robak T, Staib P, Thomas X, Cahill A, Albitar M, O'Brien S. Phase 3 randomized, placebo-controlled, double-blind study of high-dose continuous — View Citation
Giles FJ, Stock W, Vey N, et al.: A double blind placebo-controlled randomized phase III study of high dose continuous infusion cytosine arabinoside (araC) with or without cloretazine in patients with first relapse of acute myeloid leukemia (AML). [Abstra
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate | No | ||
Secondary | Time to tumor progression | No | ||
Secondary | Duration of response | No | ||
Secondary | Overall response | No | ||
Secondary | Toxicity | Yes |
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