Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06016179
Study type Interventional
Source Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Contact Patrick Wagner, MD
Phone 412-359-3731
Email patrick.wagner@ahn.org
Status Recruiting
Phase Phase 1
Start date January 30, 2024
Completion date January 2027

See also
  Status Clinical Trial Phase
Completed NCT00052338 - Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Phase 1
Recruiting NCT04793607 - Interventions for Malignant Pleural Effusions Impact on Fatigue
Recruiting NCT03987087 - A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC Phase 2
Recruiting NCT02942043 - Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer Phase 2
Completed NCT01997190 - Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion Phase 1
Completed NCT00564733 - FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Phase 2
Not yet recruiting NCT04131231 - Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion N/A
Completed NCT02674243 - Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion Phase 3
Terminated NCT01004510 - Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer Phase 2
Completed NCT00528645 - AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer Phase 2
Recruiting NCT00313066 - Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion Phase 4
Terminated NCT04236037 - Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura N/A
Completed NCT05372055 - Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
Not yet recruiting NCT04914598 - A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions Phase 3
Recruiting NCT04322136 - AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion N/A
Recruiting NCT03973957 - Talc Outpatient Pleurodesis With Indwelling Catheter N/A
Recruiting NCT05923515 - A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion Phase 1
Completed NCT02649894 - Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter N/A
Recruiting NCT03403855 - Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients N/A
Terminated NCT03597009 - A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion Phase 1/Phase 2