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Sponsors and Collaborators: |
University of Kentucky National Institutes of Health (NIH) |
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Information provided by: | University of Kentucky |
ClinicalTrials.gov Identifier: | NCT00382954 |
The purpose of this study is to determine the maximal tolerated dose (MTD) of bortezomib and idarubicin given in combination to newly diagnosed AML patients >60 years or relapsed AML patients.
Another purpose of this study is to determine the dose limiting toxicities associated with bortezomib in combination with idarubicin in newly diagnosed AML patients >60 years or relapsed AML patients.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia |
Drug: Velcade Drug: Idarubicin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study Using Bortezomib (Velcade, Formerly Known as PS-341) With Weekly Idarubicin for the Treatment of Elderly (>/= 60 Years) and Relapsed Patients With Acute Myelogenous Leukemia |
Estimated Enrollment: | 55 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Phase 1 escalation: Experimental |
Drug: Velcade
velcade (4 original dosing levels with 3 modified dosing levels) I.V. on days 1, 4, 8, 11, 15, 18, 22, and 25 for 4 weeks concurrent with the Idarubicin
Drug: Idarubicin
I.V., 8, or 10 or 12 mg/m^2 weekly (days 1, 8, 15, and 22) for 4 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Melissa Wayland | 859-257-3379 | mwayla2@email.uky.edu |
Contact: Dianna Howard, MD | 859-323-5768 | dshowa0@email.uky.edu |
United States, Kentucky | |
University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Melissa Wayland 859-257-3379 mwayla2@email.uky.edu | |
Contact: Dianna Howard, MD 859-323-5768 dshowa0@email.uky.edu | |
Principal Investigator: Dianna Howard, MD | |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Jane Liesveld, MD 585-275-4099 jane_liesveld@urmc.rochester.edu | |
Principal Investigator: Jane Liesveld, MD |
Principal Investigator: | Dianna Howard, MD | University of Kentucky |
Responsible Party: | University of Kentucky ( Dianna Howard, MD ) |
Study ID Numbers: | 03-BMT-145 |
Study First Received: | September 28, 2006 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00382954 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Acute Myelogenous Leukemia AML Relapse Elderly |
Velcade Idarubicin Bortezomib |
Leukemia Idarubicin Bortezomib Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antibiotics, Antineoplastic Pharmacologic Actions Protease Inhibitors |