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Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00357305 |
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as cytarabine and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with cytarabine and etoposide may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with cytarabine and etoposide in treating patients with relapsed or refractory acute leukemia or myelodysplastic syndromes or myeloproliferative disorders.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cytarabine Drug: etoposide Drug: vorinostat Genetic: microarray analysis Genetic: protein expression analysis Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Vorinostat (Suberoylanilide Hydroxamic Acid, or SAHA) in Combination With Cytosine Arabinoside (Ara-C) and Etoposide for Patients With Relapsed and/or Refractory Acute Leukemias, Myelodysplasias and Myeloproliferative Disorders |
Estimated Enrollment: | 25 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of vorinostat (SAHA).
Patients receive oral SAHA two or three times daily on days 1-7 and cytarabine IV over 3 hours twice daily and etoposide IV over 1 hour once daily on days 11-14. Treatment repeats approximately every 6-7 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after 1 course of therapy may receive 1 or 2 more courses of therapy. Patients who achieve partial response after
1 course of therapy may receive 1 more course of therapy.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose.
Blood, buccal cells, and bone marrow samples are collected prior to and during treatment. Samples are used for pharmacokinetic and pharmacodynamic studies, protein expression studies, and gene expression profiling.
After completion of study treatment, patients are followed within 30 days.
PROJECTED ACCRUAL: A total of 25 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:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Relapsed or refractory acute myeloid leukemia (AML)
Patients with acute promyelocytic leukemia t(15;17) must have failed prior tretinoin and arsenic trioxide-containing regimen
Chronic myelogenous leukemia in accelerated or blastic phase
Must be refractory to treatment with imatinib mesylate or dasatinib
PATIENT CHARACTERISTICS:
No other uncontrolled illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Recovered from prior therapy
No more than 3 prior courses of induction/reinduction chemotherapy, including induction and consolidation therapy or induction therapy after any bone marrow transplantation or similar procedure
Prior allogeneic stem cell transplantation allowed if all of the following criteria are met:
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 |
Study Chair: | Douglas D. Ross, MD, PhD | University of Maryland School of Medicine |
Study ID Numbers: | CDR0000487484, MSGCC-0447, NCI-6829, MSGCC-H-27631 |
Study First Received: | July 26, 2006 |
Last Updated: | June 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00357305 History of Changes |
Health Authority: | Unspecified |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia secondary acute myeloid leukemia recurrent adult acute lymphoblastic leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute promyelocytic leukemia (M3) relapsing chronic myelogenous leukemia atypical chronic myeloid leukemia previously treated myelodysplastic syndromes |
secondary myelodysplastic syndromes de novo myelodysplastic syndromes adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) adult acute basophilic leukemia adult acute eosinophilic leukemia chronic myelomonocytic leukemia chronic eosinophilic leukemia |
Anticarcinogenic Agents Anti-Inflammatory Agents Polycythemia Anti-Infective Agents Blast Crisis Chronic Myelomonocytic Leukemia Preleukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Acute Myeloid Leukemia, Adult Neoplasm Metastasis Leukemia, Promyelocytic, Acute Thrombocythemia, Hemorrhagic Etoposide Myelodysplastic Myeloproliferative Disease |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Erythroblastic, Acute Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Antineoplastic Agents, Phytogenic Di Guglielmo's Syndrome Leukemia, Monocytic, Acute Antimetabolites Leukemia, Lymphoid Immunologic Factors |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Etoposide phosphate Leukemia Preleukemia Pathologic Processes Sensory System Agents |
Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Etoposide Cytarabine Neoplasms by Histologic Type Disease Hematologic Diseases Myelodysplastic Syndromes Vorinostat Myeloproliferative Disorders Enzyme Inhibitors Protective Agents Immunosuppressive Agents |