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New treatment option for Malignant Pleural Effusion
Official title Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
ClinicalTrials.gov ID: NCT06016179
What this study is testing
What is Tocilizumab?
Tocilizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for malignant pleural effusion.
Also referred to as Actemra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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...
- 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
You likely can't join if
- Pediatric patients
- Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT \> 2 times the upper limit of normal ALT/SGPT \> 2 times...
- ECOG \> 3
- people 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...
See the full eligibility 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...
- 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
- 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...
- ECOG \> 3
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.