Neoplasms

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Gland and Hormone Related Diseases

Rare Diseases

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Gastrointestinal Diseases

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Endocrine System Diseases

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Irinotecan

Fluorouracil

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Folfirinox

Pancrelipase

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Immunosuppressive Agents

Immunologic Factors

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8-weeks of anakinra and modified FOLFIRINOX regimen (refer to Appendix 9 for regimen) as follows

Kineret (anakinra) Dosage Route Administration 100 mg SC Every Other Day

Modified FOLFIRINOX Drug Dose Administration Oxaliplatin 85 mg/m2 2-4 hours Irinotecan 180 mg/m2 90 minutes fluorouracil 2400 mg/m2 48 hours

Dosage Route Administration 100 mg SC Every Other Day

anakinra

fluorouracil

Carlos Becerra, MD

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.

A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy

A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients

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).

Overall Survival (OS) rate as defined by the percentage of people who are alive for a certain period of time after diagnosis

Adverse events associated with injection site reactions and the incidence of infections

Data Collection: tumor measurements by CT scans

* Blood transcriptional profiling
* Composition of white blood cells
* Assessment of PDAC antigen--specific T cell repertoire in the blood

Baylor Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy	NCT02021422	Pancreas Cancer	anakinra Oxaliplatin Irinotecan fluorouracil	18 Years -	Baylor Research Institute
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy	NCT02021422	Pancreas Cancer	anakinra Oxaliplatin Irinotecan fluorouracil	18 Years -	Baylor Research Institute

Spots Global Cancer Trial Database for metastatic pancreatic ductal adenocarcinoma (pdac)