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

NCT06016179 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2023-137
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Pleural Effusion; Malignant Ascites

Keywords

Malignant Pleural Effusion; Malignant Ascites; Tocilizumab; IL-6 receptor antagonist; peritoneal cavity; pleural cavity; intraperitoneal; intrapleural

Outcome Measures

Primary Outcomes (2)

• Successful intra-cavitary administration of tocilizumab

  Number of patients with successful administration of tocilizumab

  6 weeks

• 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 Outcomes (5)

• Pharmacokinetics Analysis

  4 weeks

• Pharmacokinetics Analysis

  4 weeks

• Biomarkers

  4 weeks

• Biomarkers

  4 weeks

• Biomarkers

  4 weeks

Study Arms (1)

Treatment Arm - intracavitary tocilizumab

EXPERIMENTAL

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.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

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.

Also known as: Actemra

Treatment Arm - intracavitary tocilizumab

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ages 18-89 years
• Female patients must have a negative pregnancy test and agree to use contraception. Female patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 90 days after the last dose of tocilizumab. Male patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 60 days after the last dose of tocilizumab.
• Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites
• Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement
• ECOG 0-2
• Able to read and understand consent in English and provide informed consent

You may not qualify if:

• Pediatric patients
• 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 \> 2.5 mg/dL Hemoglobin \< 7 mg/dL White blood cell count \< 3,000/ mm3 Platelet count \< 70,000/mm3 Absolute neutrophil cell count \< 2,000 per mm3
• ECOG \> 3
• Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
• Pregnant and lactating women
• 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
• Investigational drug use within 30 days prior to first treatment dose
• History of systemic autoimmune disease (CRS, GCA, PJIA, RA, and SJIA)
• Patient with known hypersensitivity to tocilizumab (IL-6)
• Active infection
• Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine

Sponsors & Collaborators

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

Study Sites (1)

Allegheny Health Network Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Patrick Wagner, MD

  Director of Complex General Surgical Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Wagner, MD

CONTACT

412-359-3731; patrick.wagner@ahn.org

AHN Clinical Trial Contact

CONTACT

412-359-3731; clinicaltrials@ahn.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Intra-patient dose escalation administration of tocilizumab via pleural and peritoneal catheters

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 29, 2023
• Study Start: January 30, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)