Leukemia Clinical Trial
Official title:
Phase I Study of Vidaza and Velcade (Bortezomib) in Acute Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy, such as azacytidine work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing.
Bortezomib may stop the growth of cancer cells by blocking blood flow to the cancer and by
blocking some of the enzymes needed for cell growth. Giving azacytidine together with
bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when
giving together with azacytidine in treating patients with relapsed or refractory acute
myeloid leukemia or myelodysplastic syndromes.
OBJECTIVES:
Primary
- To determine the maximum tolerated dose (MTD) bortezomib in combination with Azacytidine
in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic
syndromes (MDS).
- To define the specific toxicities and the dose limiting toxicity (DLT) of Azacytidine
plus bortezomib combination.
Secondary
- To determine the overall response rate (ORR).
- To determine the rate of complete remission (CR) of Azacytidine plus bortezomib in
relapsed/refractory AML and MDS.
- To correlate the biological activity of Azacytidine as demethylating agent (changes in
target gene methylation and gene expression, DNMT1 protein expression, global
methylation) with clinical endpoints and plasma pharmacokinetics of azacytidine.
- To characterize the biological activity of bortezomib as a potential demethylating
agent.
- To correlate intracellular concentration of azacytidine-triphosphate with global DNA
methylation and other biological endpoints as well as clinical response.
- To explore the biologic role of microRNAs in determining clinical response to the
azacytidine plus bortezomib combination and achievement of the other pharmacodynamic
endpoints.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive azacytidine IV over 30 minutes on days 1-7 and bortezomib IV on days 2 and 5
or on days 2, 5, and 9 or on days 2, 5, 9, and 12. Treatment repeats every 28 days for up to
12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib and tipifarnib until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for at least 30 days.
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