NCT06016179 Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
| NCT ID | NCT06016179 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
| Condition | Malignant Pleural Effusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2026-01 |
Trial Parameters
Eligibility Fast-Check
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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.
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 \>