Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal (NCT05751837) | Clinical Trial Compass
CompletedPhase 1
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
United States10 participantsStarted 2023-03-16
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]