VELCADE in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia
Summary
The primary objective of this study is to establish the maximally tolerated dose of VELCADE that can be administered with idarubicin and cytarabine in patients with AML. The secondary objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade when combined with Cytarabine and idarubicin. Various molecular markers associated with response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray analyses. The study endpoints are maximum tolerated dose and response to treatment.
Study Design
Allocation: Non-Randomized, Control: Dose Comparison, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Leukemia
Intervention
velcade, Idarubicin, Cytarabine
Location
Massachusetts General Hospital
Boston
Massachusetts
United States
02114
Status
Completed
Source
Massachusetts General Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00505700
- Information obtained from ClinicalTrials.gov on October 22, 2010
Medical and Biotech [MESH] Definitions
Cytarabine
A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)
Ancitabine
Congener of CYTARABINE that is metabolized to cytarabine and thereby maintains a more constant antineoplastic action.
Abelson Murine Leukemia Virus
A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.
Friend Murine Leukemia Virus
A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) producing leukemia of the reticulum-cell type with massive infiltration of liver, spleen, and bone marrow. It infects DBA/2 and Swiss mice.
Moloney Murine Leukemia Virus
A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) arising during the propagation of S37 mouse sarcoma, and causing lymphoid leukemia in mice. It also infects rats and newborn hamsters. It is apparently transmitted to embryos in utero and to newborns through mother's milk.
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