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

NCT05751837 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2022-263
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Cancer; Malignancy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  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 Outcomes (1)

• Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors

  30 days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Injection of Lipopolysaccharide into one abdominal tumor

Biological: Lipopolysaccharide

Interventions

Lipopolysaccharide BIOLOGICAL

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

Also known as: LPS; E. coli 0113

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patrick Wagner, MD, FACS: lead
• List Biological Laboratories, Inc: collaborator

Study Sites (2)

Allegheny Health Network Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Allegheny Health Network West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (19)

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MeSH Terms

Conditions

Neoplasms

Interventions

Lipopolysaccharides

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Biological Factors; Endotoxins; Bacterial Toxins; Toxins, Biological

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, AHNCI Division of Complex General Surgical Oncology

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

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 2, 2023
• Study Start: March 16, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)