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The goal of this clinical research study is to learn if sequential administration of decitabine and clofarabine can help to control myelodysplastic syndrome (MDS) better than decitabine alone. The safety of this drug combination will also be studied.
The Study Drugs:
Decitabine is designed to damage cells' DNA (genetic material), which may cause myelodysplastic marrow cells to work more like normal marrow cells.
Clofarabine is designed to interfere with the growth and development of abnormal marrow cells.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in the study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked about what drugs you may be currently taking.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If you have not had one within the last 28 days, you will have a bone marrow aspiration and, if the doctor thinks is it needed, a bone marrow biopsy to check the status of the disease. To collect a bone marrow aspirate/biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
- Women who are able to become pregnant must have a negative urine or blood (about 1 tablespoon) pregnancy test.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
- If you are in Group 1, you will receive decitabine and clofarabine.
- If you are in Group 2, you will receive only decitabine.
Study Drug Administration:
Each cycle is 4-8 weeks depending on how you tolerate the drug and how the MDS responds to it.
If you are in Group 1, you will receive the drugs in an alternating series of cycles. This means that you will receive decitabine for the first 3 cycles, then clofarabine for the next 3 cycles, and then repeat. This pattern will continue for up to 24 cycles.
On Days 1-5 of Cycles 1-3, 7-9, 13-15, and 19-21, you will receive decitabine by vein over 1-2 hours.
On Days 1-5 of Cycles 4-6, 10-12, 16-18, and 22-24, you will receive clofarabine by vein over 1-2 hours.
If you are in Group 2, you will receive decitabine by vein over 1-2 hours on Days 1-5 of every cycle.
On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
Once a week, blood (about 1-2 teaspoons) will be drawn for routine tests.
At the end of Cycle 3, you will have a bone marrow aspirate to check the status of the disease.
If the disease has not gone into remission after Cycle 3, your next bone marrow aspirate will depend on your group. If you are in Group 1, you may have another aspirate about 3 weeks after you begin Cycle 4. After that, you may have an aspirate every 2 weeks (or more often if your doctor feels it is needed) until the response (or lack thereof) is confirmed. If you are in Group 2, you may not have another bone marrow aspirate until after the end of Cycle 6.
You will need to stay in Houston to receive the study drug(s). When you have study visits where you are not receiving study drug(s), these tests can be performed by your local doctor.
Length of Study:
You will be on study for up to 24 cycles. You will be taken off study early if the disease gets worse or you experience any intolerable side effects.
After your last dose of study drug, you will have follow-up visits. You will only have these visits if the disease has responded to the study drug.
Once a month, blood (about 1 tablespoon) will be drawn routine tests. This can be done at home through your local cancer doctor.
Every 6 months, you will return to Houston for a physical exam and blood (about 1 tablespoon) will be drawn for routine tests.
This is an investigational study. Clofarabine is FDA approved and commercially available for use in pediatric patients with a type of blood cancer (acute lymphocytic leukemia -- ALL). Its use in patients with MDS is investigational.
Decitabine is FDA approved and commercially available for use in patients with MDS.
Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The University of Texas M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:22:07-0400
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