Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal (LPS)

April 19, 2023 updated by: Patrick Wagner, MD, FACS
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

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Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network Allegheny General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick M. Wagner, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Allegheny Health Network West Penn Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick M. Wagner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

  7. History of allergic reaction to the investigational agent carrier solution.
  8. Medical contra-indication or allergic reaction to acetaminophen or NSAIDs.
  9. Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
  10. Adverse events from prior therapy that have not resolved to CTCAE version 5 grade < and equal to1 prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 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.
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patrick Wagner, MD, FACS

Collaborators

List Biological Laboratories, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Anticipated)

February 2, 2026

Study Completion (Anticipated)

February 28, 2027

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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