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| Sponsor: | New York Cancer Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00392353 |
Purpose
RATIONALE: Vorinostat may stop the growth of cancer or abnormal 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 or abnormal cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with azacitidine may kill more cancer or abnormal cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vorinostat and azacitidine in treating patients with myelodysplastic syndromes or acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: azacitidine Drug: vorinostat |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I/II Study of Vorinostat [Suberoylanilide Hydroxamic Acid (SAHA)] in Combination With Azacitidine in Patients With the Myelodysplastic Syndrome (MDS) |
| Estimated Enrollment: | 85 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by an open-label phase II study.
Cohorts of 3-6 patients receive escalating doses of azacitidine and vorinostat (SAHA) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed monthly for 6 months and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for the phase I portion of this study. A total of 37 patients will be accrued for the phase II portion of this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Myelodysplastic syndromes (MDS) meeting the following criteria:
One of the following types by FAB classification:
Patients with RA or RARS and IPSS ≤ 0.5 or low-risk MDS (IPSS < 0.5) must meet ≥ 1 of the following criteria:
Acute myeloid leukemia (AML) meeting the following criteria*:
De novo AML or AML evolving from MDS associated with intermediate- or poor-risk cytogenetics and meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled concurrent illness, including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
More than 1 month since prior hematopoietic growth factors, including any of the following:
No prior antimetabolites, including the following:
Contacts and Locations| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Samir S. Parekh, MD 718-920-4826 sparekh@montefiore.org | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900 | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Lewis R. Silverman, MD 212-241-5520 lewis.silverman@mssm.edu | |
| New York Weill Cornell Cancer Center at Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
| Study Chair: | Lewis R. Silverman, MD | Mount Sinai School of Medicine |
More Information
| Responsible Party: | Albert Einstein Cancer Center at Albert Einstein College of Medicine ( Joseph A. Sparano ) |
| Study ID Numbers: | CDR0000511887, NYCC-6898, NCI-6898 |
| Study First Received: | October 25, 2006 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00392353 History of Changes |
| Health Authority: | Unspecified |
|
adult acute minimally differentiated myeloid leukemia (M0) recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) secondary acute myeloid leukemia chronic myelomonocytic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia with ringed sideroblasts |
refractory anemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute promyelocytic leukemia (M3) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute megakaryoblastic leukemia (M7) secondary myelodysplastic syndromes adult acute myeloid leukemia with inv(16)(p13;q22) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Sensory System Agents Syndrome Therapeutic Uses |
Azacitidine Anti-Inflammatory Agents, Non-Steroidal Analgesics Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Vorinostat Enzyme Inhibitors Leukemia, Myeloid Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents |