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A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02021422
Recruitment Status : Unknown
Verified January 2017 by Baylor Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the study drug.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Drug: anakinra Drug: Oxaliplatin Drug: Irinotecan Drug: fluorouracil Phase 1

Detailed Description:

Kineret (anakinra) is a FDA-approved drug indicated for rheumatoid arthritis. Anakinra is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Anakinra blocks the biologic activity of IL -1 by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic effects including inflammatory and immunological responses.

This is a pilot, prospective, non-randomized, consecutive enrollment study that will enroll up to 12 subjects who meet the study defined inclusion and exclusion criteria.

Subjects will undergo standard of care chemotherapy treatment/regimens (i.e., modified FOLFIRINOX). Subjects will be dispensed a 2 weeks supply of anakinra the day they begin chemotherapy. They will be instructed to begin self-administering the anakinra (study drug) injections the day after their first dose of chemotherapy.

They will have a blood sample collected at baseline and 6 months follow up. If they have surgery for their disease, they may have a tissue sample collected for later analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients
Study Start Date : June 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Anakinra with Modified Folfirinox

8-weeks of anakinra and modified FOLFIRINOX regimen (refer to Appendix 9 for regimen) as follows

Kineret (anakinra) Dosage Route Administration 100 mg SC Every Other Day

Modified FOLFIRINOX Drug Dose Administration Oxaliplatin 85 mg/m2 2-4 hours Irinotecan 180 mg/m2 90 minutes fluorouracil 2400 mg/m2 48 hours

Drug: anakinra
Dosage Route Administration 100 mg SC Every Other Day
Other Name: Kineret

Drug: Oxaliplatin
Oxaliplatin 85 mg/m2 2-4 hours

Drug: Irinotecan
Irinotecan 180 mg/m2 90 minutes
Other Name: Camptosar

Drug: fluorouracil
fluorouracil 2400 mg/m2 48 hours
Other Name: 5 FU

Primary Outcome Measures :
  1. The Number of Participants with SAEs and AEs. [ Time Frame: 6 months ]
    Test the safety of Anakinra in combination with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) as evidenced by the Number of Participants with serious adverse events (SAEs) and adverse events (AEs).

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 6 months ]
    Overall Survival (OS) rate as defined by the percentage of people who are alive for a certain period of time after diagnosis

  2. Adverse events associated with injection site reactions and the incidence of infections [ Time Frame: 6 Months ]
    Adverse events associated with injection site reactions and the incidence of infections

  3. Data Collection: tumor measurements by CT scans [ Time Frame: 6 months ]
    Data Collection: tumor measurements by CT scans

  4. Gather preliminary information on the immune modulation and clinical activity of this therapy [ Time Frame: 6 month ]
    • Blood transcriptional profiling
    • Composition of white blood cells
    • Assessment of PDAC antigen--specific T cell repertoire in the blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • Male or non-pregnant and non-lactating female
  • Confirmed metastatic/inoperable metastatic pancreas cancer and/or Histologically/cytologically confirmed metastatic adenocarcinoma of pancreas
  • Patients' blood counts and blood chemistry levels at baseline must be not clinically significant (NCS) as determined by the enrolling investigator.
  • Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 2 (refer to Appendix 5):
  • Signed study consent form

Exclusion Criteria:

  • <18 years of age
  • Pregnant or lactating female
  • Patient has islet cell neoplasms
  • Active secondary malignancies (2nd cancer not treated/present)
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Known infection with hepatitis B, hepatitis C, or cirrhosis
  • Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
  • History of allergy or hypersensitivity to the study drugs
  • Patient is enrolled in any concurrent-outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
  • Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled CHF, or prior MI last 6-months
  • Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
  • Peripheral sensory neuropathy ≥ to grade 2 at baseline
  • Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
  • Study consent form not signed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02021422

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United States, Texas
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
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Principal Investigator: Carlos Becerra, MD Baylor Sammons Cancer Center

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Responsible Party: Baylor Research Institute Identifier: NCT02021422    
Other Study ID Numbers: 013-018
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by Baylor Research Institute:
metastatic pancreatic ductal adenocarcinoma (PDAC)
pancreatic cancer
pancreas cancer
pancreatic adenocarcinoma
metastatic pancreas cancer
metastatic pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Interleukin 1 Receptor Antagonist Protein
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antirheumatic Agents