drugset
drugset / Trial / NCT00331513

Vorinostat and Idarubicin in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndromes

NCT00331513 ↗

Phase 1 Completed 40 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase I trial is studying the side effects and best dose of vorinostat when given together with idarubicin in treating patients with relapsed or refractory leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as vorinostat and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with idarubicin may kill more cancer cells.

Timeline

Start
2006-03
Primary completion
2010-01
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Comparator Idarubicin Small molecule — Intravenous
Comparator Vorinostat Small molecule — Oral

Indications

acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) acute myeloid leukemia with multilineage dysplasia acute myeloid leukemia with t(8;21)(q22;q22) translocation acute promyelocytic leukemia adult acute lymphoblastic leukemia blast phase chronic myelogenous leukemia, BCR-ABL1 positive myelodysplastic syndrome myelodysplastic/myeloproliferative disease