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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Baylor Research Institute
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT02021422
First received: December 20, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Pancreas Cancer
Drug: anakinra
Drug: Oxaliplatin
Drug: Irinotecan
Drug: fluorouracil
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • The Number of Participants with SAEs and AEs. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Overall Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Overall Survival (OS) rate as defined by the percentage of people who are alive for a certain period of time after diagnosis

  • Adverse events associated with injection site reactions and the incidence of infections [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Adverse events associated with injection site reactions and the incidence of infections

  • Data Collection: tumor measurements by CT scans [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Data Collection: tumor measurements by CT scans

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


Estimated Enrollment: 12
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Oxaliplatin
Drug: Irinotecan
Irinotecan 180 mg/m2 90 minutes
Other Name: Camptosar
Drug: fluorouracil
fluorouracil 2400 mg/m2 48 hours
Other Name: 5 FU

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021422

Contacts
Contact: Stephanie Peschka, RN 214-818-7942 stephanie.peschka@baylorhealth.edu
Contact: Carlos Becerra, MD 214-380-1901 carlos.becerra@usoncology.com

Locations
United States, Texas
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Stephanie Peschka, RN    214-818-7942    stephanie.peschka@baylorhealth.edu   
Principal Investigator: Carlos Becerra, MD         
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Carlos Becerra, MD Baylor Sammons Cancer Center
  More Information

Additional Information:
Publications:

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02021422     History of Changes
Other Study ID Numbers: 013-018
Study First Received: December 20, 2013
Last Updated: December 27, 2013
Health Authority: United States: Data and Safety Monitoring Board

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:
Adenocarcinoma
Carcinoma, Ductal, Breast
Pancreatic Neoplasms
Breast Diseases
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Skin Diseases
Fluorouracil
Irinotecan
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014