Actively Recruiting
Phase I Dose Escalation Study of Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Malignant Pleural Effusion or Ascites Due to 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of delivering tocilizumab, an IL-6 receptor antagonist, directly into the chest or abdominal cavities of patients with malignant pleural effusions or malignant ascites caused by metastatic cancer. This Phase 1, open-label study focuses on patients who already have chest or abdominal drains placed to relieve fluid buildup from cancer. The study aims to understand the frequency and types of side effects from this method of drug delivery. Participants will receive four weekly doses of tocilizumab administered through the catheters placed in their body cavities. The doses increase incrementally each week, starting at 0.5 micrograms per milliliter and rising to 1.6, 5, and finally 50 micrograms per milliliter. Each treatment session lasts about one hour. Blood samples are collected before and after each infusion, and fluid drained via the catheters is also collected for analysis. Throughout the study, researchers will monitor immune system responses by analyzing blood and cavity fluid, track any adverse events, and assess how the drug behaves in the body. The total participation time is expected to be no more than 10 weeks. The study includes regular outpatient visits for treatment and assessments, with a focus on safety and how well the drug can be administered using this approach.
CONDITIONS
Brief 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 aged 18 to 89 years
- Female participants must have a negative pregnancy test and agree to use contraception during and after the study
- Biopsy-proven cancer diagnosis with evidence of malignant pleural effusion or ascites
- Scheduled for placement of a pleural or peritoneal drainage catheter as part of standard care
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Able to understand and provide informed consent in English
You will not qualify if you...
- Pediatric patients
- Significant laboratory abnormalities indicating active inflammation or organ dysfunction (such as elevated liver enzymes, bilirubin, creatinine, low hemoglobin, low white blood cell or platelet counts, low neutrophil count)
- ECOG performance status greater than 3
- Inability to comply with study procedures including travel for weekly outpatient visits
- Pregnant or breastfeeding women
- Active immunotherapy within 30 days prior to treatment; prior immunotherapy must be >30 days before first dose
- Use of investigational drugs within 30 days prior to first treatment
- History of systemic autoimmune diseases like cytokine release syndrome, giant cell arteritis, juvenile arthritis, or rheumatoid arthritis
- Known allergy to tocilizumab
- Active infections
- Medical contraindications or history of adverse reactions to acetaminophen or diphenhydramine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive four weekly incremental doses of tocilizumab delivered via pleural or peritoneal catheters. Each treatment session lasts about one hour and includes blood collection before and after dosing.
4 weekly visits (in-person)
Duration - Up to 6 weeks
Participants are monitored for safety and to assess treatment effects after completing the dosing schedule.
Visits as needed for safety monitoring
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
A
AHN Clinical Trial 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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