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Immunomodulating Agents

Injection of Lipopolysaccharide into one abdominal tumor

One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute

Lipopolysaccharide

Patrick M Wagner, MD

Pamela M White, BSN

Patrick M. Wagner, MD

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

Single-arm, open label, comparative, phase I safety and feasibility study, with correlative translational studies

Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal

No identifiable data will be used for future study without first obtaining IRB approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers before sharing data.

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.

Changes in intra-tumoral leukocyte subgroup densities and soluble immune biomarker concentrations will be assessed in injected tumors and compared against non-injected tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal	NCT05751837	Abdominal Cance... Malignancy	Lipopolysacchar...	18 Years - 99 Years	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal	NCT05751837	Abdominal Cance... Malignancy	Lipopolysacchar...	18 Years - 99 Years	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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