This study is being conducted to examine the safety of the investigational drug, Xilonix(™), in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a syndrome that includes involuntary weight loss and physical deterioration that can contribute to poor outcomes of cancer treatment. In other studies, Xilonix has increased lean body mass in advanced cancer patients. This increase could lead to improved weight maintenance and quality of life.
This study will prospectively evaluate advanced pancreatic adenocarcinoma patients. The intervention will be interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy. The first aim is to assess the safety and identify the maximum tolerated dose of Onivyde with 5-fluorouracil/folinic acid in combination with the study agent, Xilonix. The study will also create a repository of serum, tissue, and fecal specimens to investigate novel biomarkers related to cachexia with pancreatic adenocarcinoma and interleukin-1-alpha blockade. Lastly, the study will assess for a correlation between cachexia, activity, and PROs on domains of quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Xilonix by IV
Cedars-Sinai Medical Center
Los Angeles, California, United States
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the determination of the Maximum Tolerated Dose (MTD)
Assess safety of novel combination
Time frame: 28 days (first cycle)
Maximum Tolerated Dose (MTD) of onivyde, 5-fluorouracil/folinic acid in combination with Xilonix
Assess MTD of Onivyde in combination with novel therapy
Time frame: 28 days (first cycle)
Weight stability
Mean change from baseline (kg) up to 6 months
Time frame: 6 months
Lean Body Mass
Mean change from baseline (kg) up to 6 months
Time frame: 6 months
Overall Survival
To measure overall survival up to 12 months from baseline
Time frame: 12 months
Progression Free Survival
To measure progression free survival up to 12 months from baseline
Time frame: 12 months
Mean change in global quality of life (QOL) score (EORTC Pan26)
Assessment based on patient-reported QOL up to 6 months from baseline
Time frame: 6 months
Mean change in global score of patient-reported response to therapy (FAACT questionnaire- Functional Assessment of Anorexia/Cachexia Therapy)
Assessment based on patient-reported outcomes up to 6 months from baseline
Time frame: 6 months
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