Tocilizumab for Malignant Pleural Effusion and Ascites

This study is testing if tocilizumab can be safely given directly into the chest or belly of patients with advanced cancer that has caused fluid buildup (malignant pleural effusion or malignant ascites). Tocilizumab is an immunotherapy and targeted therapy. You would receive four weekly doses of tocilizumab through a catheter (a thin tube) already in place. Each dose will be slightly higher than the last. Researchers will watch for any side effects and see if the drug can be given successfully. This is a small study, planning to enroll 12 participants aged 18 to 89 years old. The study is currently recruiting patients.

Study design
This is an open-label, Phase 1 study where all 12 participants will receive tocilizumab, with the dose increasing each week. It is designed to see if the treatment is feasible and to identify any side effects.
What's involved
You would have four weekly infusions of tocilizumab, each lasting about an hour. You would also give a small blood sample before and after each treatment, and fluid drained from your body cavity will be collected for analysis. The total study duration is expected to be no more than 10 weeks.
Compensation
Not stated in the trial record.
Follow-up
The main safety and administration outcomes are measured at 6 weeks after the start of treatment. The total study duration is expected to be no more than 10 weeks.

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NCT06016179

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

Recruiting
PHASE1Ages 18–89InterventionalTreatment
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
~12 participants
Updated 2025-05-22 on ClinicalTrials.gov
What's tested:Tocilizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful intra-cavitary administration of tocilizumab
Measured over 6 weeks
+1 more outcome measured
Malignant Pleural Effusion
Malignant Ascites
1 sites across 1 states
Pennsylvania1
  • Patrick Wagner, MD · PRINCIPAL_INVESTIGATOR · Director of Complex General Surgical Oncology

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  • Successful intra-cavitary administration of tocilizumab6 weeks

    Number of patients with successful administration of tocilizumab

  • Adverse Events6 weeks

    To identify the frequency and type of adverse events (AE) following intrapleural or intraperitoneal administration of tocilizumab at doses up to 2.5 mg (intrapleural) or 25 mg (intraperitoneal) using CTCAE v5.0