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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00723203 |
RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: panobinostat Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of LBH589, a Novel Histone Deacetylase Inhibitor, in Relapsed and Refractory Adult Patients With Acute Leukemia (AL) or in Newly Diagnosed Patients Over the Age of 60 |
Estimated Enrollment: | 74 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo peripheral blood and bone marrow sample collection at baseline and on day 28 of course 1 for correlative laboratory studies. Samples are analyzed by RT-PCR for reactivation of FANCG, FOXO3A, GADD45A, GADD45B, GADD45G, H2AX, and TP73.
After completion of study treatment, patients are followed for at least 4 weeks.
PROJECTED ACCRUAL: A total of 74 patients (37 with acute myeloid leukemia and 37 with acute lymphoblastic leukemia) 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 acute myeloid leukemia or acute lymphoblastic leukemia (ALL)
PATIENT CHARACTERISTICS:
No impaired cardiac function, including any of the following:
Bradycardia (i.e., heart rate < 50 beats per minute)
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Bernadette Pulone, RN 800-826-4673 | |
City of Hope Medical Group | Recruiting |
Pasadena, California, United States, 91105 | |
Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com |
Principal Investigator: | Mark H. Kirschbaum, MD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Mark H. Kirschbaum ) |
Study ID Numbers: | CDR0000601203, CHNMC-07174, NOVARTIS-CHNMC-07174 |
Study First Received: | July 25, 2008 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00723203 History of Changes |
Health Authority: | Unspecified |
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia |
Philadelphia Chromosome Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence |
Leukemia Lymphatic Diseases Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders Neoplasms by Histologic Type |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Leukemia, Myeloid Lymphoproliferative Disorders Leukemia, Myeloid, Acute |