Clinical trial NCT01254890
Conditions: Leukemia
Keywords: Relapsed Acute Leukemia Chronic Myelomonocytic Leukemia CMML Myelodysplastic Syndrome MDS Acute myeloid leukemia AML 5-azacitidine Azacitidine 5-aza Vidaza 5-AZC AZA-CR Ladakamycin NSC-102816 Sorafenib Nexavar BAY43-9006
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-01-01; Completion date: 2015-03-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can control the disease in patients with AML or MDS. The safety of this drug combination will also be studied.

Detailed description:
The Study Drugs:

Sorafenib is designed to block the function of important proteins in cancer cells. These proteins, when active, are partly responsible for the abnormal growth and behavior of cancer cells.

5-Azacytidine is designed to activate ("turn on") certain genes in cancer cells whose job is to fight tumors.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive 5-azacytidine either under the skin or by vein on Days 1-7 of each 28-day cycle. If by vein, the infusion will take about 10-40 minutes.

You will take sorafenib by mouth 2 times a day about 12 hours apart, with water on empty stomach, every day.

Each study cycle may last a little longer than 28 days, depending on how you are doing.

Study Visits:

Every week, blood (about 1 tablespoon) will be drawn for routine tests.

Every week for the first 6 weeks, and then as often as your doctor thinks it is needed, you will have your blood pressure measured.

Before each cycle:

* Your performance status will be recorded.
* You will have a physical exam, including measurement of your blood pressure and weight.

Before every 2-4 cycles, you will have a bone marrow aspirate to check the status of the disease.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.

Your participation on the study will be over once you have completed the end-of-treatment and follow-up visits.

End of Study Drug Administration Visit:

After you have stopped taking the study drugs, the following tests and procedures will be performed:

* Your medical history will be recorded.
* Your performance status will be recorded.
* You will have a physical exam, including measurement of your blood pressure and weight.
* You will have a bone marrow aspirate collected to check the status of disease.

This is an investigational study. Sorafenib is FDA approved and commercially available for kidney cancer and liver cancer. 5-Azacitidine is FDA approved for the treatment of MDS, but its combination with sorafenib is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days; Sorafenib 200 mg orally twice a day.
Interventions: intervention 1: Azacitidine intervention 2: Sorafenib
Intervention descriptions: intervention 1: 75 mg/m\^2 subcutaneously (SQ) or by vein (IV) daily for 7 days per 28 day cycle. intervention 2: Starting dose level 200 mg by mouth two times a day in a 28 day cycle. In Phase II, Sorafenib administered per MTD dose from Phase I. Drug doses separated by approximately 12 hours.

Protocol documents: