Phase 1 Study of Weekly Increasing Doses of Tocilizumab Delivered Through Chest or Abdominal Drains for Patients with Cancer-Related Pleural Effusion or Ascites

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.

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