5 ASA 2 DEOXYCYTIDINE (DAC) IN PATIENTS W/ ADVANCED MALIGNANCIES

$35,553M01FY2000RRNIH

University Of Southern California, Los Angeles CA

Investigators

Linked publications & trials

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Abstract

This is a phase I study of 5 Aza-2'-Deoxycytidine (DAC), a cytidine analog with activity as a demthylating agent in mammalian cells. Eligible patients will have incurable stages II or IV melanoma or other cancer with a least two surgically resectable or biopsiable lesions. The study is designed to define the oiptimal biologic dose of DAC, and evaluate the tocicity of DAC administered by twice daily extended intravenous in fusions to cohorts of three to six patients win escalating doses. The primary biologic end points to be determined in this study are increases in levels of p16 ecpression a s well as methylation changes in exon 1 of p16 in tumors. CCDL4 amd CDL6 cuc;om ;eve;s wo;; be ,easired/ Ec[ressopm ti,pr amtogem gemes <age-1. -2 amd -3, class I MHC, ICAM-1 (CD11b) will be assessed on biopsy specimans. Regression of tumor will be a clinical end point.

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