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

Launched by ALLEGHENY SINGER RESEARCH INSTITUTE (ALSO KNOWN AS ALLEGHENY HEALTH NETWORK RESEARCH INSTITUTE) · Aug 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tocilizumab to see if it can be safely given directly into the chest or abdominal areas of patients who have advanced cancer. The study focuses on patients dealing with conditions like malignant pleural effusion (fluid around the lungs) and malignant ascites (fluid in the abdomen) caused by cancer. Participants will receive a total of four doses of tocilizumab, each one given weekly, with each dose being larger than the last.

To participate in this trial, individuals must be between 18 and 89 years old and have specific fluid build-up due to metastatic cancer. They should also be scheduled for a standard procedure to place a drainage catheter for the fluid. However, people with certain health issues, active infections, or those who are pregnant cannot join the study. Participants can expect to visit the outpatient clinic weekly for their treatments, and they will be closely monitored for safety throughout the trial. This study is currently recruiting participants, and it aims to improve how we treat these complications in cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females ages 18-89 years
• • 2. 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.
• • 3. Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites
• • 4. Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement
• • 5. ECOG 0-2
• • 6. Able to read and understand consent in English and provide informed consent
• Exclusion Criteria:
• • 1. Pediatric patients
• • 2. 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
• • 3. ECOG \> 3
• • 4. Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
• • 5. Pregnant and lactating women
• • 6. 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
• • 7. Investigational drug use within 30 days prior to first treatment dose
• • 8. History of systemic autoimmune disease (CRS, GCA, PJIA, RA, and SJIA)
• • 9. Patient with known hypersensitivity to tocilizumab (IL-6)
• • 10. Active infection
• • 11. Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine