Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of Bortezomib in Combination With MEC (Mitoxantrone, Etoposide, and Intermediate-Dose Cytarabine) for Relapsed/ Refractory Acute Myelogenous Leukemia (AML)
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone, etoposide, 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 bortezomib together with combination
chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when
given together with mitoxantrone, etoposide, and cytarabine in treating patients with
relapsed or refractory acute myeloid leukemia.
PRIMARY OBJECTIVES:
I. To determine the DLT, MTD, and the recommended Phase 2 dose of bortezomib in combination
with MEC in patients with relapsed/refractory AML.
SECONDARY OBJECTIVES:
I. To describe the non-dose limiting toxicities associated with bortezomib in combination
with MEC in patients with relapsed/refractory AML.
II. To describe any preliminary evidence of clinical activity of this combination (CR rate)
in relapsed/refractory AML.
III. To determine the median CD74 antigen expression in patients achieving a response versus
those patients not achieving a response.
OUTLINE:
This is a dose-escalation study of bortezomib.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11; and mitoxantrone IV,
etoposide IV over 1 hour, and intermediate-dose cytarabine IV over 6 hours on days 1-6.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4-5 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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