Actively Recruiting
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Updated on 2025-05-22
12
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females ages 18-89 years
- Female patients must have a negative pregnancy test and agree to use contraception during and for 90 days after treatment
- Male patients must agree to use contraception during and for 60 days after treatment
- Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites
- Scheduled for standard-of-care pleural or peritoneal drainage catheter placement
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Able to read, understand, and provide informed consent in English
You will not qualify if you...
- Pediatric patients
- Significant laboratory abnormalities including AST/SGOT, ALT/SGPT, total bilirubin elevated more than 2 times the upper limit of normal
- Creatinine greater than 2.5 mg/dL
- Hemoglobin less than 7 mg/dL
- White blood cell count less than 3,000/mm3
- Platelet count less than 70,000/mm3
- Absolute neutrophil count less than 2,000/mm3
- ECOG performance status greater than 3
- Unable to comply with study procedures including weekly outpatient visits
- Pregnant or lactating women
- Active immunotherapy within 30 days prior; prior immunotherapy must be more than 30 days before treatment
- Investigational drug use within 30 days prior to first dose
- History of systemic autoimmune diseases such as CRS, GCA, PJIA, RA, and SJIA
- Known hypersensitivity to tocilizumab or IL-6
- Active infection
- Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine
AI-Screening
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Trial Site Locations
Total: 1 location
1
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
P
Patrick Wagner, MD
CONTACT
A
AHN Clinical Trial Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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