Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal (LPS)
Abdominal Cancer, Malignancy
About this trial
This is an interventional treatment trial for Abdominal Cancer
Eligibility Criteria
Inclusion Criteria: Males or females age 18 to 99 years Pre-menopausal women less than or equal to18 years of age must have a negative urine/serum pregnancy test prior to standard-of-care surgery and investigational treatment. Participants must have an advanced intra-abdominal tumor, including metastatic or recurrent, biopsy-proven, digestive tract tumors. Participants must have at least two index non-visceral intra-abdominal tumors that are grossly visible, >1cm3 in volume, and amenable to biopsy and injection of investigational drug or control solution at the time of laparoscopy. Participants must be planning or scheduled to undergo a standard-of-care abdominal laparoscopic surgical procedure at AGH or WPH and be potentially eligible for a second, definitive operation to remove the tumor(s) pending the findings during laparoscopy. Must be able to read and understand English and consent for themselves Exclusion Criteria: Pregnant or lactating females Investigational drug use within 30 days prior to enrollment. Immunosuppressive medication including corticosteroids within 30 days prior to enrollment. Active chemotherapy or radiotherapy within 4 weeks of investigational agent injection. Active infection requiring systemic therapy or causing fever >38.1 degree C or unexplained fever >38.1 degree C within seven days prior to investigational agent injection Laboratory abnormalities, drawn according to standard clinical care in anticipation of upcoming surgery outside the following limits: AST/SGOT > 1.5 times the upper limit of normal ALT/SGPT > 1.5 times the upper limit of normal Total bilirubin > 1.5 times the upper limit of normal Creatinine > 1.5 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 INR >1.5 times the upper limit of normal PTT >1.5 times the upper limit of normal History of allergic reaction to the investigational agent carrier solution. Medical contra-indication or allergic reaction to acetaminophen or NSAIDs. Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Adverse events from prior therapy that have not resolved to CTCAE version 5 grade < and equal to1 prior to enrollment
Sites / Locations
- Allegheny Health Network Allegheny General HospitalRecruiting
- Allegheny Health Network West Penn HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Treatment Arm
Injection of Lipopolysaccharide into one abdominal tumor