The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.
Males or females ages 18-89 years
Female patients must have a negative pregnancy test and agree to use contraception. Female patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 90 days after the last dose of tocilizumab. Male patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 60 days after the last dose of tocilizumab.
Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites
Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement
Pediatric patients
Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT > 2 times the upper limit of normal ALT/SGPT > 2 times the upper limit of normal Total bilirubin > 2 times the upper limit of normal Creatinine > 2.5 mg/dL Hemoglobin < 7 mg/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3
ECOG > 3
Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
Single group
Tocilizumab
DrugEach patient will receive four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.
Successful intra-cavitary administration of tocilizumab
Number of patients with successful administration of tocilizumab
Adverse Events
To identify the frequency and type of adverse events (AE) following intrapleural or intraperitoneal administration of tocilizumab at doses up to 2.5 mg (intrapleural) or 25 mg (intraperitoneal) using CTCAE v5.0
Pharmacokinetics Analysis
Measuring serum receptor occupancy levels
Pharmacokinetics Analysis
Measuring intracavity fluid receptor occupancy levels
Biomarkers
Change in Pleural cytokine concentrations
Biomarkers
Change in Peritoneal Cytokine concentrations
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