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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00101179 |
RATIONALE: MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving MS-275 together with azacitidine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 when given together with azacitidine in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes |
Drug: azacitidine Drug: entinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Dose-Finding Trial of the Histone Deacetylase Inhibitor MS-275 (NSC 706995) in Combination With 5-Azacitidine (5AC, NSC 102816) in Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMMoL) and Acute Myeloid Leukemia |
Estimated Enrollment: | 63 |
Study Start Date: | November 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of MS-275.
Patients receive azacitidine subcutaneously on days 1-10 and oral MS-275 on days 3 and 10. Courses repeat every 28 days 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. Patients receive adjusted doses of azacitidine based on clinical response. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 9 additional patients are treated at the MTD.
NOTE: *Patients who do not achieve hematologic improvement or partial or complete response but who have stable disease after 4 courses of therapy may receive an additional 4 courses of therapy at a higher dose than what was originally assigned
PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed myelodysplastic syndromes (MDS) by bone marrow aspiration and/or biopsy
Acute myeloid leukemia (AML)
Untreated AML allowed provided patient meets ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 |
Principal Investigator: | Steven D. Gore, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000405841, JHOC-J0443, NCI-6591, JHOC-04061109 |
Study First Received: | January 7, 2005 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00101179 |
Health Authority: | United States: Food and Drug Administration |
chronic myelomonocytic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia secondary acute myeloid leukemia |
Myelodysplastic syndromes Precancerous Conditions Chronic myelomonocytic leukemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence |
Leukemia, Myelomonocytic, Acute Myelodysplastic myeloproliferative disease Leukemia Signs and Symptoms Preleukemia Azacitidine Neoplasm Metastasis Acute myeloid leukemia, adult Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Acute myelocytic leukemia |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Pathologic Processes Disease Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Pharmacologic Actions |