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RECRUITING
NCT06016179
PHASE1

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

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-01-30

Completion Date

2027-01

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

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.

Locations (1)

Allegheny Health Network Cancer Institute

Pittsburgh, Pennsylvania, United States