A Phase II Study of MS-275, in Combination With GM-CSF Treating Relapsed and Refractory Myeloid Malignancies
Recruitment status was: Not yet recruiting
This research is being done to see if the combination of sargramostim and MS-275 will help to improve the bone marrow function of people with myelodysplastic syndrome (MDS) or acute myeloid leukemia(AML).
It will also determine the side effects of this combination.
Acute Myeloid Leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- All patient initiated on combination therapy will be evaluable for toxicity. Efficacy will be evaluated following two cycles of therapy.
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||April 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466115
|United States, Maryland|
|Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||B.Douglas Smith, MD||Johns Hopkins University|
|Study Chair:||Katy Rogers, RN||Johns Hopkins University|