Spots Global Cancer Trial Database for Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Study Description

Brief 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.

Detailed Description: This is an open label, Phase 1, intra-patient dose escalation study to determine the feasibility of catheter-based intra-pleural and intra-peritoneal administration of tocilizumab at doses up to 50μg/mL in patients with malignant pleural effusions (MPE) and malignant ascites (MA) and to determine the frequency and type of adverse events. Tocilizumab is a monoclonal antibody inhibitor of the IL-6 receptor, FDA-approved for intravenous administration in autoimmune disorders and cytokine release syndrome. The current study aims to adapt this agent for intra-cavitary administration in patients A drain catheter will be placed in the patient as standard of care treatment. Following the procedure, on that day and once a week for the following 3 weeks, tocilizumab will be administered to the patient via the drain. Each treatment session will last about one hour, and participants donate 6 milliliters (1 teaspoon) of blood before and after the treatment. Fluid drained from the body cavity, which is normally discarded, will instead be collected for analysis.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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