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Lipopolysaccharide Immunotherapy for Abdominal Cancer (LPS Trial)

Phase 1
Recruiting
Research Sponsored by Patrick Wagner, MD, FACS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

LPS Trial Summary

This trial studies the safety of injecting a chemical into abdominal tumors before larger surgery to remove them. Tumors will be biopsied before and after to measure any effects.

Who is the study for?
This trial is for adults aged 18-99 with advanced intra-abdominal tumors visible during laparoscopy, who are scheduled for surgery to remove these tumors. They must not be pregnant, lactating, or have had recent immunosuppressive treatments and should not have severe allergies to the study's substances or significant lab abnormalities.Check my eligibility
What is being tested?
Researchers are testing if injecting Lipopolysaccharide (LPS), a sterile bacterial component, into abdominal tumors is safe during preliminary laparoscopic surgery before a major operation. The effect of LPS will be assessed by comparing biopsies taken before injection and at the time of tumor removal.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site within the tumor, general inflammation due to immune response activation by LPS, fever, and possibly allergic reactions in those sensitive to components similar to LPS.

LPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Alteration in Cellular and Soluble Immune Biomarkers in Injected Tumors

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT02876601
81%
Headache
38%
Flu-like Symptoms
19%
Chills
13%
Nausea
13%
Arthralgia
6%
Precollapse
6%
Dizziness
6%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Defibrotide Plus LPS
Placebo Plus LPS
Defibrotide Plus Placebo
Placebo/Placebo

LPS Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Injection of Lipopolysaccharide into one abdominal tumor
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipopolysaccharide
2017
Completed Phase 4
~260

Find a Location

Who is running the clinical trial?

Patrick Wagner, MD, FACSLead Sponsor
List Biological Laboratories, IncUNKNOWN

Media Library

Treatment Arm Clinical Trial Eligibility Overview. Trial Name: NCT05751837 — Phase 1
Abdominal Cancer Research Study Groups: Treatment Arm
Abdominal Cancer Clinical Trial 2023: Treatment Arm Highlights & Side Effects. Trial Name: NCT05751837 — Phase 1
Treatment Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05751837 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any way I can become involved in this scientific research?

"The criteria for inclusion in this study necessitates that all patients have abdominal cancer and be between the ages of majority and 99. Currently, 6 volunteers are required to take part in the experiment."

Answered by AI

Is it still possible to register for this investigation?

"Affirmative. Clinicaltrials.gov showcases that this medical examination, which was initially posted on February 28th 2023, is currently recruiting patients for participation. Six individuals are in need of recruitment from 2 distinct clinical sites."

Answered by AI

Has Treatment Arm been officially greenlit by the FDA?

"The treatment arm has been assigned a score of 1 as this is only in its first phase, and thus there are limited data available that can attest to the safety or efficacy."

Answered by AI

Can adults of any age participate in this medical experiment?

"This trial is open to applicants aged 18-99. For those younger than 18 and older than 65, there are 359 clinical trials for the former age range and 2602 trials available for the latter population."

Answered by AI

What is the cap on the number of participants in this clinical experiment?

"Confirmed. Data hosted on clinicaltrials.gov reveals that this investigation, which was first posted on February 28th 2023, is presently looking for participants. A total of 6 individuals must be enrolled from 2 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
Patrick Wagner, MD, FACS 2023. "Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05751837.
~4 spots leftby Feb 2026
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