A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
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.
|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|
- 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).
- 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
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
Dosage Route Administration 100 mg SC Every Other Day
Other Name: KineretDrug: Oxaliplatin
Oxaliplatin 85 mg/m2 2-4 hours
Other Name: OxaliplatinDrug: Irinotecan
Irinotecan 180 mg/m2 90 minutes
Other Name: CamptosarDrug: fluorouracil
fluorouracil 2400 mg/m2 48 hours
Other Name: 5 FU
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02021422
|United States, Texas|
|Baylor Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Carlos Becerra, MD||Baylor Sammons Cancer Center|