CLINICAL TRIAL: ON 01910NA IN PATIENTS WITH REFRACTORY LUKEMIA OR MYELODYSPLAST

Icahn School Of Medicine At Mount Sinai, New York NY

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: Despite progress in leukemia therapy, most adult patients with advanced or refractory hematopoietic malignancies still die from their disease. Patients with relapsed AML have a poor prognosis. Although responses to standard regimens do occur, durable remissions are achieved infrequently and current regimens are not curative in the majority of patients. A subset of relapsed patients treated aggressively may have extended disease free survival;however, cures in patients following a relapse are thought to be more commonly achieved using expensive and risky bone marrow transplantation. However, most patients do not have suitable donors and the relapse rate following transplantation remains high. The antitumor effects of ON 01910.Na on a broad spectrum of tumor cell lines in culture and animal models, including many drug resistant cell lines, and its high therapeutic index, provide a strong rationale for clinical studies in the treatment of cancer patients. This study is for patients who have a diagnosis of an advanced cancer, which cannot be cured with present knowledge and for which no other therapy is known to be consistently effective. This research study will use ON01910.Na, a new anticancer agent, which is investigational (has been approved by the Food and Drug Administration for study but not for sale).