Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT04926467

Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

Conditions: Pancreatic Adenocarcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 24
Sponsor: Baylor Research Institute

Location: Baylor University Medical Center, Charles A Sammons Cancer Center Dallas Texas

Summary

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.

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. \ 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04926467). StuddyBuddy aggregates publicly available trial information.