A Phase II Study of an Oral Histone Deacetylase Inhibitor, MS-275 (NSC 706995), in Combination With Sargramostim (GM-CSF, Berlex, Inc.) Treating Relapsed and Refractory Myeloid Malignancies
MDS is an abnormality of the bone marrow and blood cells that may develop into cancer.
AML is a cancer of the bone marrow and blood cells. Both result in problems making normal
blood cells. The cells in the bone marrow do not undergo the normal expected patterns of
growth or maturation that is called “differentiation.” Because of this, they do not work
very well. People with these problems often need blood transfusions and are at high risk for
infections and bleeding.
Treatment options for MDS and AML are often limited due to their side effects. We hope to
develop combinations of drugs that will help the bone marrow function better without many of
the side effects of traditional chemotherapy treatments.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
All patient initiated on combination therapy will be evaluable for toxicity. Efficacy will be evaluated following two cycles of therapy.
B.Douglas Smith, MD
Principal Investigator
Johns Hopkins University
United States: Institutional Review Board
NCI Protocol : #7605
NCT00466115
April 2007
April 2007
Name | Location |
---|---|
Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |