Acute Myelogenous Leukemia Clinical Trial
Official title:
Ph I/II Study of PTK 787 (Vatalanib) and Gleevec (Imatinib) in Patients With Refractory Acute Myelogenous Leukemia (AML), Agnogenic Myeloid Metaplasia (AMM), and Chronic Myelogenous Leukemia- Blastic Phase (CML-BP)
The goal of this clinical research study is to find the highest safe doses of PTK 787 (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous Leukemia-Blastic Phase (CML-BP), Refractory Acute Myelogenous Leukemia (AML), or Agnogenic Myeloid Metaplasia (AMM). Another goal is to see how effective this combination treatment is.
Rationale: The purpose of this study is to combine PTK-787, a potent orally vascular
endothelial growth factor (VEGF) receptor inhibitor (in disorders where VEGF is known to be
involved in the pathophysiology), with Imatinib mesylate (IM), a protein-tyrosine kinase
inhibitor of abl, Bcr-Abl, platelet derived growth factor (PDGF), and c-Kit (in same
disorders where these kinases are believed to be important). The potential synergy between
oral agents that inhibit these kinases in disorders where each of the two agents have some,
but inadequate, single agent activity is being studied in this protocol. We will also have
an opportunity to assess if there is any correlation between response and individual kinase
mutations e.g., c-Kit in patients with AML. If improved outcomes are observed, further
studies will be indicated to investigate which, if either, agent is predominantly
responsible for such a benefit - these studies will be facilitated by the availability of
more potent e.g., (AMN107 as an abl inhibitor), (Bevacizumab, AG013736 as VEGF inhibitors)
agents which will help to define the relative importance of the various inhibitory
activities.
Objectives: To determine the maximum tolerated doses (MTD) and pharmacokinetics (PK) of PTK
787 and imatinib mesylate, when given in combination to patients with refractory acute
myelogenous leukemia (AML), agnogenic myeloid metaplasia (AMM) and chronic myelogenous
leukemia in blastic phase (CML-BP).
To determine the efficacy (response rate, survival, time to progression, time to treatment
failure, duration of response) of the MTD in these study populations.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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