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

Sponsor
Patrick Wagner, MD, FACS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05751837
Collaborator
List Biological Laboratories, Inc (Other)
6
Enrollment
2
Locations
1
Arm
48
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Lipopolysaccharide
 Phase 1

Detailed Description

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 Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single-arm, open label, comparative, phase I safety and feasibility study, with correlative translational studiesSingle-arm, open label, comparative, phase I safety and feasibility study, with correlative translational studies
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Feb 2, 2026
Anticipated Study Completion Date :
Feb 28, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Arm

Injection of Lipopolysaccharide into one abdominal tumor

Biological: Lipopolysaccharide
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute
Other Names:
  • LPS; E. coli 0113

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [30 Days]

      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.

    Secondary Outcome Measures

    1. Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors [30 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Males or females age 18 to 99 years

    2. 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.

    3. Participants must have an advanced intra-abdominal tumor, including metastatic or recurrent, biopsy-proven, digestive tract tumors.

    4. 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.

    5. 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.

    6. Must be able to read and understand English and consent for themselves

    Exclusion Criteria:

    1. Pregnant or lactating females

    2. Investigational drug use within 30 days prior to enrollment.

    3. Immunosuppressive medication including corticosteroids within 30 days prior to enrollment.

    4. Active chemotherapy or radiotherapy within 4 weeks of investigational agent injection.

    5. 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

    6. 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

    1. History of allergic reaction to the investigational agent carrier solution.

    2. Medical contra-indication or allergic reaction to acetaminophen or NSAIDs.

    3. Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

    4. Adverse events from prior therapy that have not resolved to CTCAE version 5 grade < and equal to1 prior to enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allegheny Health Network Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    2 Allegheny Health Network West Penn Hospital Pittsburgh Pennsylvania United States 15224

    Sponsors and Collaborators

    • Patrick Wagner, MD, FACS
    • List Biological Laboratories, Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Patrick Wagner, MD, FACS, Director, AHNCI Division of Complex General Surgical Oncology, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
    ClinicalTrials.gov Identifier:
    NCT05751837
    Other Study ID Numbers:
    • 2022-263
    First Posted:
    Mar 2, 2023
    Last Update Posted:
    Mar 2, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Mar 2, 2023