The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the study drug.
Kineret (anakinra) is a FDA-approved drug indicated for rheumatoid arthritis. Anakinra is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Anakinra blocks the biologic activity of IL -1 by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic effects including inflammatory and immunological responses. This is a pilot, prospective, non-randomized, consecutive enrollment study that will enroll up to 12 subjects who meet the study defined inclusion and exclusion criteria. Subjects will undergo standard of care chemotherapy treatment/regimens (i.e., modified FOLFIRINOX). Subjects will be dispensed a 2 weeks supply of anakinra the day they begin chemotherapy. They will be instructed to begin self-administering the anakinra (study drug) injections the day after their first dose of chemotherapy. They will have a blood sample collected at baseline and 6 months follow up. If they have surgery for their disease, they may have a tissue sample collected for later analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Dosage Route Administration 100 mg SC Every Other Day
Oxaliplatin 85 mg/m2 2-4 hours
Irinotecan 180 mg/m2 90 minutes
Baylor Sammons Cancer Center
Dallas, Texas, United States
The Number of Participants with SAEs and AEs.
Test the safety of Anakinra in combination with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) as evidenced by the Number of Participants with serious adverse events (SAEs) and adverse events (AEs).
Time frame: 6 months
Overall Survival
Overall Survival (OS) rate as defined by the percentage of people who are alive for a certain period of time after diagnosis
Time frame: 6 months
Adverse events associated with injection site reactions and the incidence of infections
Adverse events associated with injection site reactions and the incidence of infections
Time frame: 6 Months
Data Collection: tumor measurements by CT scans
Data Collection: tumor measurements by CT scans
Time frame: 6 months
Gather preliminary information on the immune modulation and clinical activity of this therapy
* Blood transcriptional profiling * Composition of white blood cells * Assessment of PDAC antigen--specific T cell repertoire in the blood
Time frame: 6 month
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fluorouracil 2400 mg/m2 48 hours