To hear about similar clinical trials, please enter your email below
Trial Title:
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
NCT ID:
NCT05751837
Condition:
Abdominal Cancer
Malignancy
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
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 studies
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Lipopolysaccharide
Description:
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one
minute
Arm group label:
Treatment Arm
Other name:
LPS; E. coli 0113
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Allegheny Health Network Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrick M Wagner, MD
Phone:
412-359-3731
Email:
Patrick.Wagner@ahn.org
Contact backup:
Last name:
Pamela M White, BSN
Phone:
412-330-6044
Email:
Pamela.White2@ahn.org
Investigator:
Last name:
Patrick M. Wagner, MD
Email:
Principal Investigator
Facility:
Name:
Allegheny Health Network West Penn Hospital
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrick M Wagner, MD
Phone:
412-359-3731
Email:
Patrick.Wagner@ahn.org
Contact backup:
Last name:
Pamela M White, BSN
Phone:
412-330-6044
Email:
Pamela.White2@ahn.org
Investigator:
Last name:
Patrick M. Wagner, MD
Email:
Principal Investigator
Start date:
March 16, 2023
Completion date:
February 28, 2027
Lead sponsor:
Agency:
Patrick Wagner, MD, FACS
Agency class:
Other
Collaborator:
Agency:
List Biological Laboratories, Inc
Agency class:
Other
Source:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751837
