RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2024-01-30

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06016179

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.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Patrick Wagner, MD

CONTACT

412-359-3731

patrick.wagner@ahn.org

AHN Clinical Trial Contact

CONTACT

412-330-6151

clinicaltrials@ahn.org

Principal Investigator

Patrick Wagner, MD

PRINCIPAL_INVESTIGATOR

Director of Complex General Surgical Oncology

Study Locations (Sites)

Allegheny Health Network Cancer Institute

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-30

Study Completion Date2027-01

Study Record Updates

Study Start Date2024-01-30

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Malignant Pleural Effusion
Malignant Ascites