Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
NCT ID: NCT05751837
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2023-03-16
2024-05-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Injection of Lipopolysaccharide into one abdominal tumor
Lipopolysaccharide
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute
Interventions
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Lipopolysaccharide
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
99 Years
ALL
No
Sponsors
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List Biological Laboratories, Inc
UNKNOWN
Patrick Wagner, MD, FACS
OTHER
Responsible Party
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Patrick Wagner, MD, FACS
Director, AHNCI Division of Complex General Surgical Oncology
Locations
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Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Allegheny Health Network West Penn Hospital
Pittsburgh, Pennsylvania, United States
Countries
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References
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Chicoine MR, Won EK, Zahner MC. Intratumoral injection of lipopolysaccharide causes regression of subcutaneously implanted mouse glioblastoma multiforme. Neurosurgery. 2001 Mar;48(3):607-14; discussion 614-5. doi: 10.1097/00006123-200103000-00032.
Mariani CL, Rajon D, Bova FJ, Streit WJ. Nonspecific immunotherapy with intratumoral lipopolysaccharide and zymosan A but not GM-CSF leads to an effective anti-tumor response in subcutaneous RG-2 gliomas. J Neurooncol. 2007 Dec;85(3):231-40. doi: 10.1007/s11060-007-9415-2. Epub 2007 Jun 14.
Goto S, Sakai S, Kera J, Suma Y, Soma GI, Takeuchi S. Intradermal administration of lipopolysaccharide in treatment of human cancer. Cancer Immunol Immunother. 1996 May;42(4):255-61. doi: 10.1007/s002620050279.
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van Lier D, Geven C, Leijte GP, Pickkers P. Experimental human endotoxemia as a model of systemic inflammation. Biochimie. 2019 Apr;159:99-106. doi: 10.1016/j.biochi.2018.06.014. Epub 2018 Jun 22.
Fong YM, Marano MA, Moldawer LL, Wei H, Calvano SE, Kenney JS, Allison AC, Cerami A, Shires GT, Lowry SF. The acute splanchnic and peripheral tissue metabolic response to endotoxin in humans. J Clin Invest. 1990 Jun;85(6):1896-904. doi: 10.1172/JCI114651.
Calvano SE, Coyle SM. Experimental human endotoxemia: a model of the systemic inflammatory response syndrome? Surg Infect (Larchmt). 2012 Oct;13(5):293-9. doi: 10.1089/sur.2012.155. Epub 2012 Oct 16.
Vila G, Riedl M, Resl M, van der Lely AJ, Hofland LJ, Clodi M, Luger A. Systemic administration of oxytocin reduces basal and lipopolysaccharide-induced ghrelin levels in healthy men. J Endocrinol. 2009 Oct;203(1):175-9. doi: 10.1677/JOE-09-0227. Epub 2009 Jul 8.
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Mehta RS, Nishihara R, Cao Y, Song M, Mima K, Qian ZR, Nowak JA, Kosumi K, Hamada T, Masugi Y, Bullman S, Drew DA, Kostic AD, Fung TT, Garrett WS, Huttenhower C, Wu K, Meyerhardt JA, Zhang X, Willett WC, Giovannucci EL, Fuchs CS, Chan AT, Ogino S. Association of Dietary Patterns With Risk of Colorectal Cancer Subtypes Classified by Fusobacterium nucleatum in Tumor Tissue. JAMA Oncol. 2017 Jul 1;3(7):921-927. doi: 10.1001/jamaoncol.2016.6374.
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Otto F, Schmid P, Mackensen A, Wehr U, Seiz A, Braun M, Galanos C, Mertelsmann R, Engelhardt R. Phase II trial of intravenous endotoxin in patients with colorectal and non-small cell lung cancer. Eur J Cancer. 1996 Sep;32A(10):1712-8. doi: 10.1016/0959-8049(96)00186-4.
Millischer V, Heinzl M, Faka A, Resl M, Trepci A, Klammer C, Egger M, Dieplinger B, Clodi M, Schwieler L. Intravenous administration of LPS activates the kynurenine pathway in healthy male human subjects: a prospective placebo-controlled cross-over trial. J Neuroinflammation. 2021 Jul 17;18(1):158. doi: 10.1186/s12974-021-02196-x.
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Other Identifiers
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2022-263
Identifier Type: -
Identifier Source: org_study_id