SBIR-STTR Award

Human tumor clonogenic assays (HTCA's) are used to test tumor specimens in vitro against chemotherapeutic drugs. Currently, use of HTCA's is limited to tumor specimens obtained at diagnosis or at overt relapse. An ideal situation would be to test metastatic cells prior to relapse before drug resistance is a factor. This situation is feasible by obtaining small numbers of tumor cells from the bone marrow of patients with a variety of solid tumors. We have developed an HTCA that permits the clonogenic growth of tumor cells from the bone marrow of breast cancer patients. The advantages of this HTCA method are: (1) testing can be performed at all stages of disease when metastatic cells are present in marrow; (2) sensitivity and specificity may be improved because metastases in marrow may represent an aggressive clone of cells that are reflective of other systemic metastases; and (3) serial testing can be performed to identify emerging drug resistance as treatment proceeds. This marrow HTCA may also be ideal for in vitro pharmacologic testing of new compounds against human metastatic tumor cells in their natural marrow microenvironment and for verification of tumor cell removal by various marrow-purging techniques.Awardee's statement of the potential commercial applications of the research:The research will result in a commercially available clinical test for acquired drug resistance in tumor cells metastatic to bone marrow. We are positioned in the clinical laboratory field to offer this test in addition to our existing tests for the detection of marrow metastases. It will also be marketed to pharmaceutical companies as a technique to test new drugs against human tumor cells.National Cancer Institute (NCI)

This application proposes to extend results from a Phase I study which examined mechanisms to enhance the investigators' Micrometastases Clonogenic Assay (MCA) for the in vitro growth of tumor colonies from bone marrow specimens of breast cancer patients. Phase II studies will test the ability of the MCA assay to predict drug sensitivity/resistance in the high-dose chemotherapy/autologous bone marrow transplantation setting. The goal is to assist transplant physicians to identify those patients most likely to benefit from further treatment, such as high-dose chemotherapy, by determining the drug sensitivity/resistance of established metastatic disease prior to treatment.