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

Primary Purpose

Pancreas Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anakinra
Oxaliplatin
Irinotecan
fluorouracil
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring metastatic pancreatic ductal adenocarcinoma (PDAC), pancreatic cancer, pancreas cancer, pancreatic adenocarcinoma, metastatic pancreas cancer, metastatic pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor Sammons Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Anakinra with Modified Folfirinox

Arm Description

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

Outcomes

Primary Outcome Measures

The Number of Participants with SAEs and AEs.
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
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
Adverse events associated with injection site reactions and the incidence of infections
Data Collection: tumor measurements by CT scans
Data Collection: tumor measurements by CT scans
Gather preliminary information on the immune modulation and clinical activity of this therapy
Blood transcriptional profiling Composition of white blood cells Assessment of PDAC antigen--specific T cell repertoire in the blood

Full Information

First Posted
December 20, 2013
Last Updated
January 30, 2017
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02021422
Brief Title
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
Official Title
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
metastatic pancreatic ductal adenocarcinoma (PDAC), pancreatic cancer, pancreas cancer, pancreatic adenocarcinoma, metastatic pancreas cancer, metastatic pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anakinra with Modified Folfirinox
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
anakinra
Other Intervention Name(s)
Kineret
Intervention Description
Dosage Route Administration 100 mg SC Every Other Day
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 85 mg/m2 2-4 hours
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar
Intervention Description
Irinotecan 180 mg/m2 90 minutes
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5 FU
Intervention Description
fluorouracil 2400 mg/m2 48 hours
Primary Outcome Measure Information:
Title
The Number of Participants with SAEs and AEs.
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival (OS) rate as defined by the percentage of people who are alive for a certain period of time after diagnosis
Time Frame
6 months
Title
Adverse events associated with injection site reactions and the incidence of infections
Description
Adverse events associated with injection site reactions and the incidence of infections
Time Frame
6 Months
Title
Data Collection: tumor measurements by CT scans
Description
Data Collection: tumor measurements by CT scans
Time Frame
6 months
Title
Gather preliminary information on the immune modulation and clinical activity of this therapy
Description
Blood transcriptional profiling Composition of white blood cells Assessment of PDAC antigen--specific T cell repertoire in the blood
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Becerra, MD
Organizational Affiliation
Baylor Sammons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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

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