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Sponsored by: |
Johns Hopkins University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00466115 |
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.
Condition | Intervention | Phase |
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Myelodysplastic Syndrome Acute Myeloid Leukemia |
Drug: MS-275 Drug: GM-CSF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 18 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In general, patients with MDS and relapsed or refractory AML, who are not eligible for a potentially curative myeloablative allogeneic stem cell transplant or who are considered poor candidates for such a procedure due to age, medical co-morbidities, or lack of a suitable donor, will be considered for participation in the proposed trial.
Disease Specific Inclusion Criteria:
Additional Criteria:
Patients must have the following end organ function:
Exclusion Criteria:
Contact: B.Douglas Smith, MD | (410) 287-2935 | smithdo@jhmi.edu |
Contact: Katy Rogers, RN | 410-614-1766 | krogers7@jhmi.edu |
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 |
Study ID Numbers: | NCI Protocol : #7605 |
Study First Received: | April 25, 2007 |
Last Updated: | April 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00466115 |
Health Authority: | United States: Institutional Review Board |
MDS AML |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Myeloproliferative Disorders Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia Preleukemia Bone Marrow Diseases Acute myelocytic leukemia |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |