NCT06016179

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

Phase I Intra-patient Dose Escalation Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Pleural Effusion or Peritoneal Ascites Due to Metastatic Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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. This study is open to patients who have had or are having chest or abdomen drains placed during cancer treatment to relieve pressure due to buildup of cancerous fluid. Some patients have drains that are temporary (single-use), while others have drains that are left in place (indwelling) for repeated or continuous at-home drainage. Research participants, in addition to the standard treatment above, will undergo a series of four weekly infusions of the study drug into the body cavities, using the drains to inject the drug. The dose of the drug will be increased at each of the four visits. Each treatment session will last about one hour, and participants donate 12 milliliters (1 tablespoon) of blood before and after the treatment. Fluid drained from the body cavity, which is normally discarded, will instead be collected for analysis. Researchers will analyze the blood and fluid for markers of your immune system's reaction to the drug. The total study duration is expected to be no more than 10 weeks.

Conditions

• Malignant Pleural Effusion
• Malignant Ascites

Interventions

Type	Name	Description
DRUG	Tocilizumab	Each patient will receive four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.

Timeline

• Start date: 2024-01-30
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2023-08-29
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study