This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator. Hypothesis: 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). This is an open-label, dose-escalating Phase I study of ON 01910.Na in ambulatory patients with advanced cancers, who have satisfied the inclusion/exclusion criteria enumerated in this protocol. Patients will receive ON 01910.Na intravenously by 3-day continuous infusion every 2 weeks, until evidence of disease progression, specific adverse events quantified by an established scale of the National Cancer Institute to reach a level of grade 3 (out of 4) in two patients in a cohort of 4 to 6 patients, or withdrawal of patient consent. After the Recommended Phase II Dose has been determined, up to an additional 12 patients may be added to confirm the appropriateness of the Recommended Phase II Dose. This regimen of a 3-day continuous infusion every 2 weeks, is an interesting and appropriate alternative dose regimen to the 2-hour, twice a week infusion schedule for 3 weeks with 10 days recovery, that is currently under investigation under a different protocol (04-01) at The Johns Hopkins University Oncology Center. Five patients have been studied for up to six doses. The only toxic side effect that has occurred was grade 1 diarrhea in one patient (possibly drug related).

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000071-44
Application #
7605323
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-03-01
Project End
2008-02-29
Budget Start
2007-03-01
Budget End
2008-02-29
Support Year
44
Fiscal Year
2007
Total Cost
$52,884
Indirect Cost
Name
Mount Sinai School of Medicine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
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