Infusing tocilizumab into chest and abdominal cavities for advanced cancer patients
Phase I Intra-patient Dose Escalation Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Pleural Effusion or Peritoneal Ascites Due to Metastatic Cancer
PHASE1 · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · NCT06016179
This study is testing if giving tocilizumab directly into the chest and abdomen can help advanced cancer patients with fluid buildup feel better and respond to treatment.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (other) |
| Drugs / interventions | tocilizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06016179 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study aims to evaluate the safety and feasibility of administering tocilizumab via pleural and peritoneal catheters in patients with malignant pleural effusions and malignant ascites. Participants will receive four weekly infusions of increasing doses of the drug, while also undergoing standard drainage procedures for fluid buildup. Blood and fluid samples will be collected to analyze the immune response to the treatment. The total duration of the study is expected to be around 10 weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-89 with biopsy-proven malignancies and evidence of malignant pleural effusion or ascites who are scheduled for catheter placement.
Not a fit: Patients with significant laboratory abnormalities or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from fluid buildup due to advanced metastatic cancer.
How similar studies have performed: While this approach is novel, similar studies using catheter-based drug delivery have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- Allegheny Health Network Cancer Institute — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Patrick Wagner, MD — Director of Complex General Surgical Oncology
- Study coordinator: Patrick Wagner, MD
- Email: patrick.wagner@ahn.org
- Phone: 412-359-3731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Pleural Effusion, Malignant Ascites, Tocilizumab, IL-6 receptor antagonist, peritoneal cavity, pleural cavity, intraperitoneal, intrapleural