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Sponsored by: |
Vion Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354276 |
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: cytarabine Drug: laromustine |
Phase II |
Study Type: | Interventional |
Study Design: | Open Label, Treatment |
Official Title: | A Phase II Study of Cloretazine® (VNP40101M) for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia |
Estimated Enrollment: | 85 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed de novo acute myeloid leukemia (AML)
Must have ≥ 1 of the following poor-risk features:
Any of the following unfavorable cytogenetics:
Cardiac dysfunction* that would limit the use of anthracycline therapy, as defined by any of the following:
Significant arrhythmia, including any of the following:
Heart valve disease
Pulmonary dysfunction not related to AML, defined by 1 of the following:
PATIENT CHARACTERISTICS:
No active, uncontrolled infection
PRIOR CONCURRENT THERAPY:
No other concurrent standard or investigational therapy for AML except for the following:
Concurrent hydroxyurea to control rising white blood cell counts
Concurrent leukapheresis to control blast cell counts
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
France | |
Hopital Haut Leveque | Recruiting |
Pessac, France, 33604 | |
Contact: Mathieu Sauvezie 33-5-5765-6018 | |
United Kingdom, Wales | |
University Hospital of Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Alison Jenkins 44-29-2074-6413 |
Investigator: | Bonny L. Johnson, RN, MSN | Vion Pharmaceuticals |
Study ID Numbers: | CDR0000492755, EUDRACT-2006-001853-89, VION-CLI-043 |
Study First Received: | July 19, 2006 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00354276 History of Changes |
Health Authority: | Unspecified |
adult acute basophilic leukemia adult acute eosinophilic leukemia adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) |
adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myelomonocytic leukemia (M4) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) untreated adult acute myeloid leukemia |
Antimetabolites Leukemia, Monocytic, Acute Acute Myelomonocytic Leukemia Leukemia, Myeloid Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Leukemia, Myelomonocytic, Acute |
Leukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Leukemia, Erythroblastic, Acute Acute Myeloid Leukemia, Adult Congenital Abnormalities Cytarabine Di Guglielmo's Syndrome |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid |
Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Cytarabine |