Infusing tocilizumab into chest and abdominal cavities for advanced cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study aims to evaluate the safety and feasibility of administering tocilizumab via pleural and peritoneal catheters in patients with malignant pleural effusions and malignant ascites. Participants will receive four weekly infusions of increasing doses of the drug, while also undergoing standard drainage procedures for fluid buildup. Blood and fluid samples will be collected to analyze the immune response to the treatment. The total duration of the study is expected to be around 10 weeks.

Why it matters

Who can join: the full rules

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

Where it's running

• Allegheny Health Network Cancer Institute
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Patrick Wagner, MD — Director of Complex General Surgical Oncology
• Study coordinator: Patrick Wagner, MD
• Email: patrick.wagner@ahn.org
• Phone: 412-359-3731

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.