Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic C… (NCT06016179) | Clinical Trial Compass
RecruitingPhase 1
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
United States12 participantsStarted 2024-01-30
Plain-language 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.
Who can participate
Age range18 Years – 89 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Successful intra-cavitary administration of tocilizumab
Timeframe: 6 weeks
2
Adverse Events
Timeframe: 6 weeks
Trial details
NCT IDNCT06016179
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
✕. 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)