Study on Chemotherapy and Anakinra for Patients with Pancreatic Cancer

Sponsor: Baylor Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04926467

Provider View

This clinical trial is exploring the use of a drug called Anakinra, combined with chemotherapy, to treat patients with pancreatic cancer. The study aims to see if this combination can improve treatment outcomes for patients undergoing surgery for pancreatic cancer.

Patient Parameters

Program Overview

This study is testing a new treatment approach for pancreatic cancer by combining a drug called Anakinra with chemotherapy. Anakinra is known to reduce inflammation, which plays a role in pancreatic cancer. The study will involve patients receiving chemotherapy before and after surgery, along with Anakinra, to see if this combination can help control the cancer more effectively.

Description

This clinical trial is being conducted by Baylor Scott and White Research Institute in Dallas. It is an open-label, single-arm study, meaning all participants will receive the same treatment.

Patients with pancreatic cancer who are scheduled for surgery will receive chemotherapy both before and after their operation. Before surgery, the chemotherapy will include Nab-paclitaxel, gemcitabine, and cisplatin. After surgery, the chemotherapy will switch to 5-Fluorouracil, oxaliplatin, and irinotecan. Anakinra will be given throughout the treatment period to help manage inflammation.

Participants will self-administer Anakinra and will also receive growth factors to help maintain their blood cell counts during chemotherapy. There will be a short break from Anakinra treatment just before surgery.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of pancreatic ductal adenocarcinoma.
  • Cancer must be resectable, locally advanced, or potentially resectable.
  • Be in stages I-III of pancreatic cancer according to the AJCC.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood and organ function as determined by specific medical tests.
  • Women and men must agree to use contraception during the study and for one month after the last dose of Anakinra.
  • Must understand and sign an informed consent form.
  • Must be available for treatment and follow-up appointments.

Exclusion Criteria

  • Under 18 years of age.
  • History of organ transplant.
  • Have islet cell tumors or stage IV pancreatic cancer.
  • Have active, uncontrolled infections or known infections with hepatitis B, hepatitis C, or HIV.
  • Have significant liver disease or cirrhosis.
  • Currently on immunosuppressive therapy.
  • Have had major surgery or a vascular device placed within two weeks before starting the study.
  • Have received prior chemotherapy or radiation for pancreatic cancer.
  • Have allergies to the study drugs.
  • Are participating in another clinical trial with investigational drugs.
  • Have been treated with Anakinra or similar drugs before.
  • Have had another cancer within the last five years, unless the risk of recurrence is very low.
  • Have significant heart disease or other severe medical conditions.
  • Have severe nerve damage or abnormal liver function tests.
  • Have low blood protein levels or abnormal blood counts.
  • Are pregnant or breastfeeding.
  • Have not signed the informed consent form.

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