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A Phase I/II Study of Decitabine and All-Trans Retinoic Acid (Tretinoin) for Patients with Myelodysplastic Syndromes
[Protocol 06-054]
- Full Title :
- PHASE I/II STUDY OF DECITABINE AND ALL-TRANS RETINOIC ACID FOR PATIENTS WITH MYELODYSPLASTIC SYNDROMES
- Purpose :
In people with myelodysplastic syndromes (MDS), the bone marrow does not work normally. As a result, they have abnormally low levels of functioning blood cells (such as red blood cells, white blood cells, and platelets).
Tretinoin is a form of vitamin A that is taken in pill form. In laboratory studies, tretinoin has been shown to induce the normal growth of white blood cells in MDS and leukemia samples. Tretinoin may help bone marrow function by helping MDS cells to grow into normal blood cells. It also appears to be able to kill MDS cells.
Decitabine is a drug that was recently approved by the FDA for treating MDS. Decitabine appears to work by "uncovering" genes that are hidden due to the effects of MDS. When these genes are uncovered, the body can use them to make normal blood cells.
Laboratory studies show that tretinoin may work better when given with decitabine. In this study, investigators want to assess the safety and effectiveness of tretinoin and decitabine when given together in patients with MDS.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of MDS.
- At least 4 weeks must have passed since any prior chemotherapy or radiation therapy and entry into the study.
- Patient cannot participate if they are allergic to parabens, vitamin A, or retinoids.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Virginia Klimek at 212-639-6519.
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