The purpose of this research study is to determine whether a sterile bacteria wall chemical, called lipopolysaccharide (LPS), can be injected safely into abdominal tumors during routine laparoscopic surgery performed as a preliminary procedure in patients who will subsequently undergo a larger planned operation to remove abdominal tumors. The researchers will biopsy the tumor before injection and then again at the time of the larger operation to assess whether any effect of the treatment can be measured.
Immunotherapy for advanced cancers of the abdomen can be quite effective, but not all tumors are responsive to this type of treatment. There is intense interest in new methods to convert non-responsive tumors into responsive tumors. One such method is to inject chemical constituents of micro-organisms into tumors in order to stimulate the immune system to recognize the tumor as foreign and mount an immune response to treatment. Provide a concise and brief, one-paragraph summary of your research project. Include a summary of the problem, the main objective and rationale of your project; a brief description of the experimental approach and methods; a concise description/summary of the most important results that you hope to obtain; and why think your results will be significant
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute
Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Allegheny Health Network West Penn Hospital
Pittsburgh, Pennsylvania, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number, nature and severity of adverse events as assessed by CTCAE v 4.0 will be determined in a series of six patients undergoing injection of bacterial-derived immunotherapeutic toll receptor agonist (LPS) instilled via direct injection into intra-abdominal tumors during laparoscopic surgery.
Time frame: 30 Days
Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors
Changes in intra-tumoral leukocyte subgroup densities and soluble immune biomarker concentrations will be assessed in injected tumors and compared against non-injected tumors.
Time frame: 30 days
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