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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06016179
Other study ID # 2023-137
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 30, 2024
Est. completion date January 2027

Study information

Verified date March 2024
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
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date January 2027
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: 1. Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to metastatic cancer 2. Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter 3. ECOG performance status: 0-2 4. Able to read and sign consent form in English and provide informed consent Exclusion Criteria: 1. Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT > 2 times the upper limit of normal ALT/SGPT > 2 times the upper limit of normal Total bilirubin > 2 times the upper limit of normal Creatinine > 2 times the upper limit of normal Hemoglobin < 8gm/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3 2. Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits 3. Pregnant women 4. Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be >30 days prior to the first treatment visit 5. Investigational drug use within 30 days prior to first treatment dose 6. History of systemic autoimmune disease 7. Patient with known hypersensitivity to tocilizumab 8. Active infection 9. Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine -

Study Design


Intervention

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

Country Name City State
United States Allegheny Health Network Cancer Institute Pittsburgh Pennsylvania

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful intra-cavitary administration of tocilizumab Number of patients with successful administration of tocilizumab 6 weeks
Primary Adverse Events 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 6 weeks
Secondary Pharmacokinetics Analysis Measuring serum receptor occupancy levels 4 weeks
Secondary Pharmacokinetics Analysis Measuring intracavity fluid receptor occupancy levels 4 weeks
Secondary Biomarkers Change in Pleural cytokine concentrations 4 weeks
Secondary Biomarkers Change in Peritoneal Cytokine concentrations 4 weeks
Secondary Biomarkers Change in immune cell density 4 weeks
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