Phase
Condition
Liver Disease
Neoplasm Metastasis
Pleural Effusion
Treatment
Tocilizumab
Clinical Study ID
Ages 18-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 contraceptivemeasures during and for a minimum of 90 days after the last dose of tocilizumab.Male patients receiving tocilizumab should maintain adequate contraceptive measuresduring and for a minimum of 60 days after the last dose of tocilizumab.
Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence ofmalignant pleural effusion or ascites
Scheduled to undergo standard-of-care pleural or peritoneal drainage catheterplacement
ECOG 0-2
Able to read and understand consent in English and provide informed consent
Exclusion
Exclusion Criteria:
Pediatric patients
Laboratory abnormalities that indicate clinically significant inflammatory processAST/SGOT > 2 times the upper limit of normal ALT/SGPT > 2 times the upper limit ofnormal Total bilirubin > 2 times the upper limit of normal Creatinine > 2.5 mg/dLHemoglobin < 7 mg/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3Absolute neutrophil cell count < 2,000 per mm3
ECOG > 3
Subjects who are unable to comply with study procedures including travel for weeklyoutpatient clinic visits
Pregnant and lactating women
Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy ispermitted but for patients with a history of prior immunotherapy, the most recentdose should be >30 days prior to the first treatment visit
Investigational drug use within 30 days prior to first treatment dose
History of systemic autoimmune disease (CRS, GCA, PJIA, RA, and SJIA)
Patient with known hypersensitivity to tocilizumab (IL-6)
Active infection
Medical contraindication or history of adverse reaction to acetaminophen ordiphenhydramine
Study Design
Study Description
Connect with a study center
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
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