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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT02021422
Phase
PHASE1
Status
Completed

Conditions

  • Pancreas Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • anakinra — DRUG
    Dosage Route Administration 100 mg SC Every Other Day
  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m2 2-4 hours
  • Irinotecan — DRUG
    Irinotecan 180 mg/m2 90 minutes
  • fluorouracil — DRUG
    fluorouracil 2400 mg/m2 48 hours

Study Details

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.

Key Dates

Start date
Dec 31, 2013
Status verified
Nov 2025
Primary completion
Dec 31, 2017
Completion
Jun 30, 2021

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 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

Primary Outcome Measure

The Number of Participants with SAEs and AEs. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Sammons Cancer CenterDallasTexas75246-

Find similar trials in Dallas, TX

By research site
Baylor Sammons Cancer Center· Dallas, TX

Related Studies