PHI-35: A PHASE I STUDY OF THE TOXICITIES, BIOLOGIC AND CLINICAL EFFECTS OF DAIL

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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. The purpose of this study is to determine the highest amount of an investigational drug, 5-Aza 2'Deoxycytidine (DAC), that can be given five days a week for five weeks without causing unmanageable side effects (the maximum tolerated dose, MTD). Another purpose is to collect preliminary information about doses of DAC that have an effect on the substances produced by tumors that control tumor growth. Another purpose is to study the levels of DAC that remain in the body over time when given at the doses and schedule used in this study. When cancer has metastasized and standard chemotherapeutic agents are ineffective, it is considered reasonable to use investigational drugs. DAC is an investigational drug that appears to act by reversing (changing back to normal) potentially cancer-causing changes in DNA of cancerous cells. Laboratory studies suggest that, by reversing these changes, the growth of cancer cells can be slowed down or stopped. This way of working is different from other chemotherapy drugs that kill cells and shrink or eliminate cancer. DAC has been used in treatment studies for leukemia, and some responses have been seen. It has also been used to a lesser extent in treatment studies in other types of cancer. DAC given at high doses over a short period of time did not work to shrink tumors. This study will evaluate whether giving DAC at lower doses for a longer period of time might change the levels of substances in tumors that cause the cancer cells to grow and so prevent cancer cells from growing in the body. To accomplish this purpose subjects with tumors that can undergo repeated biopsies will be enrolled so that laboratory tests can be done to see whether DAC causes changes in cancer cells that might have an effect on tumor growth.