Recruiting
Phase 1

Tocilizumab

Sponsor:

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Code:

NCT06016179

Conditions

Malignant Pleural Effusion

Malignant Ascites

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tocilizumab

Study Details

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.

Conditions

Malignant Pleural Effusion

Malignant Ascites

Study ID

NCT06016179

Start date

Jan 30, 2024

Status verified date

May, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm - intracavitary tocilizumab

Four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.

Interventions

Tocilizumab

Each patient will receive four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.

Primary outcome measure

  • Successful intra-cavitary administration of tocilizumab [ Time Frame: 6 weeks ]
  • Adverse Events [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Allegheny Health Network Cancer Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Patrick Wagner, MD

More Information

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Last update posted

May 22, 2025

Last verified

May, 2025

Keywords

  • Malignant Pleural Effusion
  • Malignant Ascites
  • Tocilizumab
  • IL-6 receptor antagonist
  • peritoneal cavity
  • pleural cavity
  • intraperitoneal
  • intrapleural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2025-05-22.