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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00331513 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as vorinostat and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with idarubicin may kill more cancer cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of vorinostat when given together with idarubicin in treating patients with relapsed or refractory leukemia or myelodysplastic syndromes.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: Idarubicin Drug: SAHA (Vorinostat) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat, SAHA) in Combination With Idarubicin in Relapsed or Refractory Leukemia |
| Enrollment: | 41 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 14 Days SAHA
Arm I: Oral SAHA 3x daily on Days 1-14 + Idarubicin IV over 15 minutes daily on Days 1-3, repeated every 21 days for 6 courses.
|
Drug: Idarubicin
12 mg/m^2 IV daily for 3 days on days 1 to 3 of each cycle
Other Name: Idamycin
Drug: SAHA (Vorinostat)
Starting dose level of 100 mg by mouth (PO) three times daily x 14 days for Arm 1, and 100 mg PO three times daily x 3 days for Arm 1. Cycle is every 21 days.
Other Names:
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|
Experimental: 3 Days SAHA
Arm II: Oral SAHA 3x daily on Days 1-3 + Idarubicin IV over 15 minutes daily on Days 1-3, repeated every 21 days for 6 courses
|
Drug: Idarubicin
12 mg/m^2 IV daily for 3 days on days 1 to 3 of each cycle
Other Name: Idamycin
Drug: SAHA (Vorinostat)
Starting dose level of 100 mg by mouth (PO) three times daily x 14 days for Arm 1, and 100 mg PO three times daily x 3 days for Arm 1. Cycle is every 21 days.
Other Names:
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OBJECTIVES:
OUTLINE: This is a randomized, dose-escalation study of vorinostat (SAHA). Patients are randomized to 1 of 2 treatment arms.
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 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. An additional 10 patients are treated at the MTD.
Patients undergo blood collection and bone marrow biopsies periodically during the study for pharmacologic, biomarker, and genetic studies.
After completion of study treatment, patients are followed at 4 weeks and then periodically thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Guillermo Garcia-Manero, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Guillermo Garcia-Manero MD, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00331513 History of Changes |
| Other Study ID Numbers: | 2005-0031, U01CA062461, P30CA016672, MDA-2005-0031, NCI-6892, CDR0000472062 |
| Study First Received: | May 30, 2006 |
| Last Updated: | June 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent adult acute myeloid leukemia adult acute promyelocytic leukemia (M3) 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 lymphoblastic leukemia previously treated myelodysplastic syndromes blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
secondary acute myeloid leukemia secondary myelodysplastic syndromes de novo myelodysplastic syndromes SAHA Vorinostat Zolinza MSK-390 Suberoylanilide Hydroxamic Acid Idarubicin Idamycin |
|
Leukemia Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Idarubicin |
Vorinostat Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |