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

Primary Purpose

Abdominal Cancer, Malignancy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lipopolysaccharide
Sponsored by
Patrick Wagner, MD, FACS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Injection of Lipopolysaccharide into one abdominal tumor

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors
Changes in intra-tumoral leukocyte subgroup densities and soluble immune biomarker concentrations will be assessed in injected tumors and compared against non-injected tumors.

Full Information

First Posted
February 2, 2023
Last Updated
April 19, 2023
Sponsor
Patrick Wagner, MD, FACS
Collaborators
List Biological Laboratories, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05751837
Brief Title
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
Acronym
LPS
Official Title
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
February 2, 2026 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Wagner, MD, FACS
Collaborators
List Biological Laboratories, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer, Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, open label, comparative, phase I safety and feasibility study, with correlative translational studies
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Injection of Lipopolysaccharide into one abdominal tumor
Intervention Type
Biological
Intervention Name(s)
Lipopolysaccharide
Other Intervention Name(s)
LPS; E. coli 0113
Intervention Description
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors
Description
Changes in intra-tumoral leukocyte subgroup densities and soluble immune biomarker concentrations will be assessed in injected tumors and compared against non-injected tumors.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick M Wagner, MD
Phone
412-359-3731
Email
Patrick.Wagner@ahn.org
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela M White, BSN
Phone
412-330-6044
Email
Pamela.White2@ahn.org
Facility Information:
Facility Name
Allegheny Health Network Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick M Wagner, MD
Phone
412-359-3731
Email
Patrick.Wagner@ahn.org
First Name & Middle Initial & Last Name & Degree
Pamela M White, BSN
Phone
412-330-6044
Email
Pamela.White2@ahn.org
First Name & Middle Initial & Last Name & Degree
Patrick M. Wagner, MD
Facility Name
Allegheny Health Network West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick M Wagner, MD
Phone
412-359-3731
Email
Patrick.Wagner@ahn.org
First Name & Middle Initial & Last Name & Degree
Pamela M White, BSN
Phone
412-330-6044
Email
Pamela.White2@ahn.org
First Name & Middle Initial & Last Name & Degree
Patrick M. Wagner, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
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Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal

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