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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velcade | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of bortezomib & idarubicin given in combination, with idarubicin given once weekly for 4 consecutive weeks & bortezomib given twice weekly over the same time. | week 4 | |
| Dose limiting toxicities associated with bortezomib in combination with idarubicin. | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Response to the combination of Idarubicin and Bortezomib. | Days 18 & 50 | |
| Pre- & post-treatment inhibition of NF-kB activity in the malignant & normal hematopoietic cell populations. | 24 hours after the initial dose of Bortezomib |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dianna Howard, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| University of Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24075534 | Derived | Howard DS, Liesveld J, Phillips GL 2nd, Hayslip J, Weiss H, Jordan CT, Guzman ML. A phase I study using bortezomib with weekly idarubicin for treatment of elderly patients with acute myeloid leukemia. Leuk Res. 2013 Nov;37(11):1502-8. doi: 10.1016/j.leukres.2013.09.003. Epub 2013 Sep 8. |
| Label | URL |
|---|---|
| University of Kentucky Markey Cancer Center Clinical Trials Listing | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D015255 | Idarubicin |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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|
| Idarubicin | Drug | I.V., 8, or 10 or 12 mg/m^2 weekly (days 1, 8, 15, and 22) for 4 weeks |
|
| Induction of p53 levels in the malignant cell populations. | 2 and 24 hours post day +1 Bortezomib |
| Bortezomib PK when administered to patients with acute leukemia receiving concomitant medications that could lead to drug interactions. In the case of altered pharmacokinetics, a pharmacodynamic assay to check proteasome inhibition may also be applied. | Days 1, 4, 8, 11, 15 |
| Idarubicin PK in order to observe any alteration in metabolism/elimination of Idarubicin & its active metabolite idarubicinol when it is combined with Bortezomib. | Days 1, 4, 8, 11, 15 |
| Rochester |
| New York |
| 14642 |
| United States |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |