TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexAll
- Healthy volunteersNo
You may be able to join 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 cannot join 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;
- Platelets ˂ 70,000 x 10^3/µl;
- Hemoglobin ˂ 9 g/dL (in the absence of red blood transfusion).
- Pregnant or nursing women
- No signed Informed consent form