Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 20, 2013
December 27, 2013
June 2013
December 2014   (final data collection date for primary outcome measure)
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).
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 SAEs and AEs.
Complete list of historical versions of study NCT02021422 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreas Cancer
  • 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
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

Interventions:
  • Drug: anakinra
  • Drug: Oxaliplatin
  • Drug: Irinotecan
  • Drug: fluorouracil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Stephanie Peschka, RN 214-818-7942 stephanie.peschka@baylorhealth.edu
Contact: Carlos Becerra, MD 214-380-1901 carlos.becerra@usoncology.com
United States
 
NCT02021422
013-018
Yes
Baylor Research Institute
Baylor Research Institute
Not Provided
Principal Investigator: Carlos Becerra, MD Baylor Sammons Cancer Center
Baylor Research Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP