MS-275 in Treating Patients With Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00015925|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 10, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of MS-275 in treating patients who have hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Drug: entinostat||Phase 1|
- Determine the toxic effects and pharmacokinetics of MS-275 in patients with poor-risk hematologic malignancy.
- Determine whether this drug induces changes in hematologic differentiation, in terms of changes in morphology, cell surface marker expression, and acetylation status, in these patients.
- Determine whether this drug induces clinical response in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral MS-275 on days 1, 8, 15, and 22. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Clinical-Labratory Study of the Histone Deacetylase (HDA) Inhibitor MS-275 in Adults With Refractory and Relapsed Hematologic Malignancies|
|Study Start Date :||February 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015925
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Judith E. Karp, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|