Overview

Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Status:
Recruiting
Trial end date:
2027-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Criteria
Inclusion Criteria:

1. Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to
metastatic cancer

2. Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage
catheter

3. ECOG performance status: 0-2

4. Able to read and sign consent form in English and provide informed consent

Exclusion Criteria:

1. 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 times the
upper limit of normal Hemoglobin < 8gm/dL White blood cell count < 3,000/ mm3 Platelet
count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3

2. Subjects who are unable to comply with study procedures including travel for weekly
outpatient clinic visits

3. Pregnant women

4. Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is
permitted but for patients with a history of prior immunotherapy, the most recent dose
should be >30 days prior to the first treatment visit

5. Investigational drug use within 30 days prior to first treatment dose

6. History of systemic autoimmune disease

7. Patient with known hypersensitivity to tocilizumab

8. Active infection

9. Medical contraindication or history of adverse reaction to acetaminophen or
diphenhydramine

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