Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Description

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 Overview

Study Details

Study overview

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.

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

Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Condition
Malignant Pleural Effusion
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to metastatic cancer
  • 2. Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter
  • 3. ECOG performance status: 0-2
  • 4. Able to read and sign consent form in English and provide informed consent
  • 1. 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 times the upper limit of normal Hemoglobin \< 8gm/dL White blood cell count \< 3,000/ mm3 Platelet count \< 70,000/mm3 Absolute neutrophil cell count \< 2,000 per mm3
  • 2. Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
  • 3. Pregnant women
  • 4. 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
  • 5. Investigational drug use within 30 days prior to first treatment dose
  • 6. History of systemic autoimmune disease
  • 7. Patient with known hypersensitivity to tocilizumab
  • 8. Active infection
  • 9. Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Patrick Wagner, MD, PRINCIPAL_INVESTIGATOR, Director of Complex General Surgical Oncology

Study Record Dates

2027-01