Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

Recruiting now · Phase 2

Conditions studied: Pancreatic Adenocarcinoma

In brief

Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.

Key facts

Study ID

NCT04926467

Run by

Baylor Research Institute

People needed

24

Starts

2021-07-23

Expected to finish

2027-06-01

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:
• 18 years of age or older
• Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
• Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
• American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
• Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 1
• Serum albumin ≥2.0 g/dL.
• Adequate hematologic function as defined by:
• Absolute neutrophil count (ANC) ≥1500/mm3;
• Platelets ≥70,000 x 10\^3/µl;
• Hemoglobin ≥9 g/dL (in the absence of red blood transfusion).
• Adequate liver function, as defined by:
• Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
• ALT (SGPT) and AST (SGOT) ≤2.5 x upper limit of normal (ULN).
• Adequate renal function, as defined by serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
• Women of child bearing potential and men must agree to use contraception throughout the study and for one month after the last anakinra administration.
• Subjects must understand and sign the informed consent form
• Patients must be accessible for treatment and follow-up.

You may not qualify if…

• A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
• <18 years of age
• History of organ transplant.
• Patients with islet cell neoplasms
• Patients with stage IV pancreatic carcinoma
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Known active infection with hepatitis B or hepatitis C
• Presence of clinically significant cirrhosis as determined by the investigator
• Known HIV positive status.
• Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
• Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study
• Prior chemotherapy or radiation for pancreatic cancer
• History of allergy or hypersensitivity to the study drugs
• Patient is enrolled in any outside therapeutic clinical protocol or investigational trial with an investigational drug within 5 half-lives prior to Study ID assignment
• Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor
• Other malignancy within five years(except cutaneous, non-melanoma malignancies or cervical carcinoma in site), unless the probability of recurrence of the prior malignancy is <5% as determined by the Principal Investigator based on available information.
• Significant cardiac disease (uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias) within the last six months.
• Other severe and/or uncontrolled medical conditions (e.g: prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation) or other conditions deemed by investigator as unsuitable for participation/enrollment
• Peripheral sensory neuropathy > or equal to grade 2 at baseline
• Abnormal liver function tests as follows:
• Total bilirubin of > 2 x ULN
• AST or ALT > 5x ULN
• Serum albumin ˂ 2.0 g/dL.
• Abnormal hematologic function as follows :
• Absolute neutrophil count (ANC) ˂ 1500/mm3;

Where it is running

• Baylor University Medical Center, Charles A Sammons Cancer Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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