This summary is from the Cleveland Clinic trial posting for this drug:
“Summary: The myelodysplastic syndromes (MDS) are diseases of the bone marrow stem cells that affect primarily older adults, many of whom become dependent on blood product transfusions or develop acute myeloid leukemia. The only potentially curative therapy is bone marrow transplantation, a modality only available to approximately 5% of patients with MDS. Thus, new therapies are needed. This study uses a novel therapeutic, SCIO-469, to prevent the effects of chemicals (cytokines) produced by MDS cells in the bone marrows. These chemicals prevent the growth of normal bone marrow cells, and it is hypothesized that SCIO-469 will allow that growth to occur again. Objectives include evaluating the safety and tolerability of the drug, as well as assessing the efficacy of the drug (as measured by erythroid response, response of other cell lines, and improvement in cytogenetic abnormalities) in patients with the more indolent form of MDS, with goals of demonstrating improvement of red blood cell transfusion needs and an increase in hemoglobin concentration. Patients will be given this oral drug at different doses daily for 16 weeks. Once safety has been demonstrated, a higher-dose arm will be opened and will enroll patients. Patients will continue to receive medication for up to 52 weeks. Previous studies in patients with other conditions have demonstrated improvement symptoms in patients with rheumatologic disorders and in plsam cell concentrations in patients with multiple myeloma. By participating in this national, multi-center Phase I/II trial, we hope to be part of what could be a new treatment paradigm for MDS.”
This trial will be on-going at multiple locations, including Rush Hospital. You can get a more complete listing, including pre-requisites, side effects, and other locations at http://www.clinicaltrials.gov/ct/show/NCT00113893
I am sure your doctor will have lots more to share when you go in. Hope it is successful for both of your relatives.
Laura
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