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

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

NCT ID: NCT06016179

Condition: Malignant Pleural Effusion
Malignant Ascites

Conditions: Official terms:
Neoplasm Metastasis
Pleural Effusion, Malignant
Pleural Effusion
Ascites

Conditions: Keywords:
Malignant Pleural Effusion
Malignant Ascites
Tocilizumab
IL-6 receptor antagonist
peritoneal cavity
pleural cavity
intraperitoneal
intrapleural

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Intra-patient dose escalation administration of tocilizumab via pleural and peritoneal catheters

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tocilizumab
Description: 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.
Arm group label: Treatment Arm - intracavitary tocilizumab

Other name: Actemra

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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 -

Gender: All

Minimum age: 18 Years

Maximum age: 89 Years

Healthy volunteers: No

Locations:

Facility:
Name: Allegheny Health Network Cancer Institute

Address:
City: Pittsburgh
Zip: 15213
Country: United States

Status: Recruiting

Contact:
Last name: Patrick Wagner, MD

Phone: 412-359-3731
Email: patrick.wagner@ahn.org

Contact backup:
Last name: AHN Clinical Trials Contact

Phone: 412-330-6011
Email: clinicaltrials@ahn.org

Investigator:
Last name: Patrick Wagner, MD
Email: Principal Investigator

Investigator:
Last name: Ghosh Sohini, MD
Email: Sub-Investigator

Investigator:
Last name: Catherine Lewis, MD, PhD
Email: Sub-Investigator

Investigator:
Last name: Stephanie Baltaji, MD
Email: Sub-Investigator

Start date: January 30, 2024

Completion date: January 2027

Lead sponsor:
Agency: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Agency class: Other

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06016179