Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Cyclosporine Modulation of Drug Resistance in Combination With Pravastatin, Mitoxantrone, and Etoposide for Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML): A Phase 1/2 Study
This phase I/II trial studies the side effects and best dose of etoposide and mitoxantrone hydrochloride when given together with cyclosporine and pravastatin sodium and to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia (AML). Cyclosporine may inhibit efflux of cancer drugs out of cancer cells and may thereby improve chemotherapy treatment for AML. Pravastatin sodium may stop the growth of cancer cells by blocking some of the nutrients needed for cell growth. Drugs used in chemotherapy, such as etoposide and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving cyclosporine together with pravastatin sodium, etoposide, and mitoxantrone hydrochloride may kill more cancer cells
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated doses of mitoxantrone (mitoxantrone hydrochloride) and
etoposide in combination with pravastatin (pravastatin sodium) and cyclosporine.
SECONDARY OBJECTIVES:
I. Describe the complete remission (CR)/CR with incomplete peripheral blood count recovery
(CRi) rate after up to 2 cycles of induction therapy.
II. Describe the disease-free survival of patients that achieve CR/CRi. III. Estimate the
frequency and severity of regimen-associated toxicities, along with 28-day mortality after
start of study treatment.
OUTLINE: This is a phase I/II, dose-escalation study of etoposide and mitoxantrone
hydrochloride in combination with pravastatin sodium and cyclosporine.
Patients receive cyclosporine intravenously (IV) continuously on days 5-9. Patients also
receive pravastatin sodium orally (PO) every 6 hours on days 1-10, etoposide IV continuously
on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats
for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients
achieving CR/CRi may receive 2 additional courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month.
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