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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-01-30 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \> 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
Contact & Investigator
Patrick Wagner, MD
PRINCIPAL INVESTIGATOR
Director of Complex General Surgical Oncology
Frequently Asked Questions
Who can join the NCT06016179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Malignant Pleural Effusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06016179 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06016179 currently recruiting?
Yes, NCT06016179 is actively recruiting participants. Contact the research team at patrick.wagner@ahn.org for enrollment information.
Where is the NCT06016179 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06016179 clinical trial?
NCT06016179 is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The principal investigator is Patrick Wagner, MD at Director of Complex General Surgical Oncology. The trial plans to enroll 12 participants.