drugset / Trial / NCT01249430

Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT01249430

Phase 1 Completed 24 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of azacitidine when given together with mitoxantrone, etoposide phosphate, and cytarabine in treating patients with acute myeloid leukemia that has returned after a period of improvement or does not respond to treatment. Azacitidine 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 phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Azacitidine may help mitoxantrone, etoposide phosphate, and cytarabine work better by making cancer cells more sensitive to the drugs.

Timeline

Start
2011-01-20
Primary completion
2013-05-24
Completion
2013-05-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Etoposide Small molecule Intravenous
Background Mitoxantrone Small molecule Intravenous