7-Hydroxystaurosporine and Perifosine in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia or High Risk Myelodysplastic Syndromes

NCT00301938 ↗

Phase 1 Completed 30 enrolled National Cancer Institute (NCI)

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial is studying the side effects and best dose of 7-hydroxystaurosporine when given together with perifosine in treating patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. 7-Hydroxystaurosporine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as perifosine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving 7-hydroxystaurosporine together with perifosine may kill more cancer cells.

Timeline

Start: 2005-12
Primary completion: 2012-05
Completion: —

Publications

Gojo I, Perl A, Luger S, Baer MR, Norsworthy KJ, Bauer KS, Tidwell M, Fleckinger S, Carroll M, Sausville EA. Phase I study of UCN-01 and perifosine in patients with relapsed and refractory acute leukemias and high-risk myelodysplastic syndrome. Invest New Drugs. 2013 Oct;31(5):1217-27. doi: 10.1007/s10637-013-9937-8. Epub 2013 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Perifosine	Small molecule	100 mg	Oral
Subject	UCN-01	Small molecule	40 mg/m2	Intravenous
Subject	UCN-01	Small molecule	65 mg/m2	Intravenous
Subject	UCN-01	Small molecule	90 mg/m2	Intravenous

7-Hydroxystaurosporine and Perifosine in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia or High Risk Myelodysplastic Syndromes

Summary

Timeline

Publications

Drugs

Indications