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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00357708 |
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 decitabine, 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 decitabine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and decitabine in treating patients with relapsed, refractory, or poor-prognosis hematologic cancer or other diseases.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: decitabine Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Vorinostat (IND 71976, NSC 701852) and Decitabine (IND 50733, NSC 127716) in Patients With Relapsed, Refractory, or Poor Prognosis Leukemia |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive decitabine IV over 1 hour on days 1-5 and oral vorinostat (SAHA) three times daily on days 6-19. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of decitabine and SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 50 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 confirmed hematologic cancer or other disease, including any of the following:
Acute myeloid leukemia (AML)
Chronic myelogenous leukemia (CML)
Chronic myelomonocytic leukemia or Philadelphia chromosome-negative CML allowed provided 1 of the following criteria is met:
Myelodysplastic syndromes (MDS)
PATIENT CHARACTERISTICS:
No other uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
No prior or other concurrent histone deacetylase (HDAC) inhibitors or compounds with HDAC inhibitor-like activity (e.g., valproic acid) as antitumor therapy
No concurrent prophylactic hematopoietic colony-stimulating factors
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Jean-Pierre Issa, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000489104, MDA-2005-0723, NCI-6878 |
Study First Received: | July 26, 2006 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00357708 |
Health Authority: | United States: Food and Drug Administration |
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) adult acute minimally differentiated myeloid leukemia (M0) 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 erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) |
atypical chronic myeloid leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia essential thrombocythemia myelodysplastic/myeloproliferative disease, unclassifiable Philadelphia chromosome negative chronic myelogenous leukemia polycythemia vera previously treated myelodysplastic syndromes recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia secondary myelodysplastic syndromes |
Polycythemia Philadelphia Chromosome Blast Crisis Chronic myelogenous leukemia Chronic myelomonocytic leukemia Di Guglielmo's syndrome Preleukemia Hemorrhagic thrombocythemia Neoplasm Metastasis Leukemia, Promyelocytic, Acute Thrombocythemia, Hemorrhagic Acute myeloid leukemia, adult Myelodysplastic syndromes Essential thrombocytosis Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Acute myelogenous leukemia Acute promyelocytic leukemia Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia, Erythroblastic, Acute Leukemia, Myeloid, Accelerated Phase Acute monoblastic leukemia Leukemia, Monocytic, Acute Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Neoplasms by Histologic Type Disease Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions |
Neoplasms Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |