Status:
RECRUITING
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Conditions:
Malignant Pleural Effusion
Malignant Ascites
Eligibility:
All Genders
18-89 years
Phase:
PHASE1
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...
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/...
Eligibility Criteria
Inclusion
- Males or females ages 18-89 years
- 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.
- Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites
- Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement
- ECOG 0-2
- Able to read and understand consent in English and provide informed consent
Exclusion
- Pediatric patients
- 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
- ECOG \> 3
- Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
- Pregnant and lactating women
- 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
- Investigational drug use within 30 days prior to first treatment dose
- History of systemic autoimmune disease (CRS, GCA, PJIA, RA, and SJIA)
- Patient with known hypersensitivity to tocilizumab (IL-6)
- Active infection
- Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06016179
Start Date
January 30 2024
End Date
January 1 2027
Last Update
May 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213