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RECRUITING Phase 2 ClinicalTrials.gov

Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

Sponsor: Baylor Research Institute • ClinicalTrials.gov ID: NCT04926467

Registry updated: 2026-10-15
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Description

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.

Interventions

  • Anakinra (Drug)
    Anakinra (100 mg) twice a day (BID), daily, will be self-administered subcutaneously starting on D1 of chemotherapy. Anakinra will be held 2 days prior to surgery. A dosing diary will be given to the patient for anakinra documentation.

Eligibility criteria

Inclusion Criteria: * A patient will be eligible for inclusion in this study if he or she meets all of the following criteria: 1. 18 years of age or older 2. Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma. 3. Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma 4. American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma. 5. Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 1 6. Serum albumin ≥2.0 g/dL. 7. Adequate hematologic function as defined by: 1. Absolute neutrophil count (ANC) ≥1500/mm3; 2. Platelets ≥70,000 x 10\^3/µl; 3. Hemoglobin ≥9 g/dL (in the absence of red blood transfusion). 8. Adequate liver function, as defined by: 1. Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment. 2. ALT (SGPT) and AST (SGOT) ≤2.5 x upper limit of normal (ULN). 9. Adequate renal function, as defined by serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min 10. Women of child bearing potential and men must agree to use contraception throughout the study and for one month after the last anakinra administration. 11. Subjects must understand and sign the informed consent form 12. Patients must be accessible for treatment and follow-up. Exclusion Criteria: * A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria: 1. \<18 years of age 2. History of organ transplant. 3. Patients with islet cell neoplasms 4. Patients with stage IV pancreatic carcinoma 5. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy 6. Known active infection with hepatitis B or hepatitis C 7. Presence of clinically significant cirrhosis as determined by the investigator 8. Known HIV positive status. 9. Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc. 10. Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study 11. Prior chemotherapy or radiation for pancreatic cancer 12. History of allergy or hypersensitivity to the study drugs 13. 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 14. Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor 15. 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. 16. Significant cardiac disease (uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias) within the last six months. 17. 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 18. Peripheral sensory neuropathy \> or equal to grade 2 at baseline 19. Abnormal liver function tests as follows: 1. Total bilirubin of \> 2 x ULN 2. AST or ALT \> 5x ULN 20. Serum albumin ˂ 2.0 g/dL. 21. Abnormal hematologic function as follows : 1. Absolute neutrophil count (ANC) ˂ 1500/mm3; 2. Platelets ˂ 70,000 x 10\^3/µl; 3. Hemoglobin ˂ 9 g/dL (in the absence of red blood transfusion). 22. Pregnant or nursing women 23. No signed Informed consent form

Conditions

Pancreatic Adenocarcinoma

Locations

  • Baylor University Medical Center, Charles A Sammons Cancer Center — Dallas, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record