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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00351975 |
RATIONALE: PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. 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 PXD101 together with azacitidine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PXD101 when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: azacitidine Drug: belinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase I Study of PXD101 in Combination With Azacitadine (5-Aza) for Advanced Hematologic Malignancies |
Estimated Enrollment: | 33 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of PXD101 followed by a randomized study.
Patients receive PXD101 IV over 30 minutes and azacitidine subcutaneously (SC) on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PXD101 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.
After the MTD is determined, additional patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (with trilineage dysplasia or arising from MDS) are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After receiving one course, patients randomized to arm I may crossover to receive treatment on arm II.
For patients enrolled in the randomized portion of the study, bone marrow aspirates are obtained at baseline, on day 5 of course 1, and after course 2 for correlative studies. Samples are examined by gene expression analysis of p15 and p21, DNA methylation of p15INK4B, and flow cytometry. Pharmacodynamic assays are also performed.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 33 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 diagnosis of 1 of the following:
Advanced phases of Philadelphia chromosome-negative (Ph-) chronic myeloproliferative disorders, as defined by ≥ 1 of the following:
MDS, including chronic myelomonocytic leukemia
Low-risk IPSS scores allowed provided ≥ 1 of the following criteria are met:
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, the following:
No uncontrolled cardiovascular disease, including the following:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Karen W. L. Yee, MD 416-946-4495 karen.yee@uhn.on.ca |
Study Chair: | Olatoyosi M. Odenike, MD | University of Chicago |
Study ID Numbers: | CDR0000486418, UCCRC-14510A, NCI-7285 |
Study First Received: | July 13, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00351975 |
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 myelodysplastic/myeloproliferative disease, unclassifiable previously treated myelodysplastic syndromes accelerated phase chronic myelogenous leukemia |
blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia Philadelphia chromosome negative chronic myelogenous leukemia chronic idiopathic myelofibrosis Philadelphia chromosome positive chronic myelogenous leukemia relapsing chronic myelogenous leukemia de novo myelodysplastic syndromes secondary myelodysplastic syndromes adult acute promyelocytic leukemia (M3) atypical chronic myeloid leukemia |
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Chronic myelogenous leukemia Hematologic Neoplasms Precancerous Conditions Chronic myelomonocytic leukemia Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia Preleukemia Chronic Myeloproliferative Disorders Azacitidine Leukemia, Promyelocytic, Acute Neoplasm Metastasis |
Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Myelodysplastic syndromes Myelofibrosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelodysplastic Syndromes Acute promyelocytic leukemia Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid |
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 |