An Open Label, Phase II Study of Chemotherapy + Anakinra in Patients With Resectable, Locally Advanced or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)

Trial ID: NCT04926467

Interventional - Phase 2 - Recruiting

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

• Anakinra

Eligibility

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

Sponsor

Baylor Research Institute

Source: ClinicalTrials.gov

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